Sertraline Pediatric Registry for the Evaluation of Safet... | NCT01302080 | Trialant
NCT01302080
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Status
Completed
Last Update Posted
Oct 14, 2021Actual
Enrollment
941Actual
Phase
Not provided
Conditions
Obsessive Compulsive Disorder
Interventions
sertraline
psychotherapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01302080
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A0501093
Secondary IDs
ID
Type
Description
Link
SPRITES
Other Identifier
Alias Study Number
Brief Title
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Official Title
SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS
Acronym
SPRITES
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 4, 2012Actual
Primary Completion Date
Sep 9, 2020Actual
Completion Date
Sep 9, 2020Actual
First Submitted Date
Feb 1, 2011
First Submission Date that Met QC Criteria
Feb 18, 2011
First Posted Date
Feb 23, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2021
Results First Submitted that Met QC Criteria
Sep 9, 2021
Results First Posted Date
Oct 8, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 12, 2021
Last Update Posted Date
Oct 14, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
Detailed Description
Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.
Conditions Module
Conditions
Obsessive Compulsive Disorder
Keywords
prospective
cohort
sertraline
long-term impact
cognition
emotional and physical development
pubertal maturation
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
941Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sertraline-treated
enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
Drug: sertraline
psychotherapy only
enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
Behavioral: psychotherapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
sertraline
Drug
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
Sertraline-treated
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Cognitive Function Using Trails B at Month 3
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 3
Change From Baseline in Cognitive Function Using Trails B at Month 6
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 6
Change From Baseline in Cognitive Function Using Trails B at Month 12
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.
Exclusion Criteria:
Psychotic at study entry
Diagnosis of bipolar disorder
Diagnosis of schizoaffective or schizophrenia
Anorexia
Bulimia or eating disorder not otherwise specified (NOS)
Autism
Pervasive developmental disorder
High risk of suicide within 2 weeks of initiating study treatment
Significant mental retardation
Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
16 Years
Standard Ages
Child
Study Population
The accessible population is children meeting inclusion/exclusion criteria from US centers in various clinical settings, including the Child and Adolescent Psychiatry Trials Network (CAPTN). From these, the study-eligible population (all children age 6 to 16 (inclusive) with an anxiety, depressive, or obsessive-compulsive disorder, who are exposed to sertraline under real-world conditions) will comprise an inception cohort of enrolled subjects beginning treatment for one of the study-qualifying disorders with sertraline or psychotherapy.
Kolitsopoulos F, Ramaker S, Compton SN, Broderick S, Orazem J, Bao W, Lokhnygina Y, Marschall K, Chappell P. Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES). J Child Adolesc Psychopharmacol. 2023 Feb;33(1):2-13. doi: 10.1089/cap.2022.0048.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants switched from 1 treatment to another throughout the study, irrespective in which arm they were enrolled. Hence, number of participants for reporting arms were different at different visits.
Recruitment Details
This was a non-interventional observational study. Participants to be enrolled were of age 6 to 16 (inclusive), exposed to sertraline (with or without psychotherapy) and exposed to psychotherapy alone under real world conditions. Participants exposed and unexposed to sertraline were followed for a maximum of 3 years.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sertraline
Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 24, 2019
Sep 9, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
psychotherapy
Behavioral
Non-interventional study- as above
psychotherapy only
Baseline, Month 12
Change From Baseline in Cognitive Function Using Trails B at Month 18
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 18
Change From Baseline in Cognitive Function Using Trails B at Month 24
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 24
Change From Baseline in Cognitive Function Using Trails B at Month 30
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 30
Change From Baseline in Cognitive Function Using Trails B at Month 36
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Baseline, Month 36
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 3
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 6
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 12
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 18
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 24
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 30
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 36
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 3
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 6
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 12
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 18
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 24
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 30
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Baseline, Month 36
Change From Baseline in Height at Month 3
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.
Baseline, Month 3
Change From Baseline in Height at Month 6
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 6
Change From Baseline in Height at Month 12
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 12
Change From Baseline in Height at Month 18
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 18
Change From Baseline in Height at Month 24
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 24
Change From Baseline in Height at Month 30
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 30
Change From Baseline in Height at Month 36
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 36
Change From Baseline in Weight at Month 3
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 3
Change From Baseline in Weight at Month 6
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 6
Change From Baseline in Weight at Month 12
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 12
Change From Baseline in Weight at Month 18
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 18
Change From Baseline in Weight at Month 24
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 24
Change From Baseline in Weight at Month 30
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 30
Change From Baseline in Weight at Month 36
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 36
Change From Baseline in Body Mass Index (BMI) at Month 3
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 3
Change From Baseline in Body Mass Index (BMI) at Month 6
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 6
Change From Baseline in Body Mass Index (BMI) at Month 12
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 12
Change From Baseline in Body Mass Index (BMI) at Month 18
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 18
Change From Baseline in Body Mass Index (BMI) at Month 24
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 24
Change From Baseline in Body Mass Index (BMI) at Month 30
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 30
Change From Baseline in Body Mass Index (BMI) at Month 36
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Baseline, Month 36
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Number of Participants With Tanner Staging Evaluation at Month 3: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 3
Number of Participants With Tanner Staging Evaluation at Month 6: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 6
Number of Participants With Tanner Staging Evaluation at Month 12: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 12
Number of Participants With Tanner Staging Evaluation at Month 18: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 18
Number of Participants With Tanner Staging Evaluation at Month 24: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 24
Number of Participants With Tanner Staging Evaluation at Month 30: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 30
Number of Participants With Tanner Staging Evaluation at Month 36: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 36
Number of Participants With Tanner Staging Evaluation at Baseline: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Number of Participants With Tanner Staging Evaluation at Month 3: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 3
Number of Participants With Tanner Staging Evaluation at Month 6: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 6
Number of Participants With Tanner Staging Evaluation at Month 12: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 12
Number of Participants With Tanner Staging Evaluation at Month 18: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 18
Number of Participants With Tanner Staging Evaluation at Month 24: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 24
Number of Participants With Tanner Staging Evaluation at Month 30: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 30
Number of Participants With Tanner Staging Evaluation at Month 36: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Month 36
Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.
Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.
Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Imperial
California
92251
United States
UCLA Semel institute
Los Angeles
California
90024
United States
Institute of Living/Hartford Hospital
Hartford
Connecticut
06106
United States
Comprehensive Psychiatric Care
Norwich
Connecticut
06360
United States
University of Florida
Gainesville
Florida
32610
United States
Nemours Children's Clinic, Dept. of Psychology and Psychiatry
Jacksonville
Florida
32207
United States
Medical Research Group of Central Florida
Orange City
Florida
32763
United States
Harmonex Neuroscience of Pensacola
Pensacola
Florida
32502
United States
University of South Florida - Rothman Center
St. Petersburg
Florida
33701
United States
Georgia Regents University Augusta
Augusta
Georgia
30912
United States
Institute for Behavioral Medicine, LLC
Smyrna
Georgia
30080
United States
Family Behavioral Health
Plainfield
Illinois
60585
United States
University of Kansas School of Medicine/Dept. of Psychiatry
Kansas City
Kansas
66160-7341
United States
Family Service and Guidance Center
Topeka
Kansas
66606
United States
Kennedy Krieger Institute
Baltimore
Maryland
21205
United States
Neuroscientific Insights
Rockville
Maryland
20852
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Debora A. LaMonica, MD
South Yarmouth
Massachusetts
02664
United States
Baystate Medical Center, Child Behavioral Health Research
Springfield
Massachusetts
01199
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Comprehensive Psychiatric Associates
Gladstone
Missouri
64118
United States
Saint John's Clinic
Springfield
Missouri
65804
United States
Jersey Shore University Medical Center/Meridian Health
Neptune City
New Jersey
07753
United States
Children's Specialized Hospital
Toms River
New Jersey
08755
United States
Finger Lakes Clinical Research
Rochester
New York
14618
United States
3-C Family Services, P.A.
Cary
North Carolina
27513
United States
Duke University Medical Center, Division of Child & Adolescent Psychiatry
Durham
North Carolina
27705
United States
Scott George Crowder, M.D.
Wilmington
North Carolina
28401
United States
Family Center by the Falls
Chagrin Falls
Ohio
44023
United States
University Of Cincinnati
Cincinnati
Ohio
45219
United States
Cincinnati Childrens Hospital and Medical Center
Cincinnati
Ohio
45220
United States
Case Western Reserve University, Department of Psychiatry Child/Adolescent
Cleveland
Ohio
44106
United States
Cutting Edge Research Group
Oklahoma City
Oklahoma
73116
United States
Child Guidance Resource Center
Havertown
Pennsylvania
19083
United States
Tullahoma Pediatrics PLLC
Tullahoma
Tennessee
37388
United States
University of Texas Southwestern Medical Center at Dallas
Dallas
Texas
75235
United States
Bay Pointe Behavioral Health Service, Inc.
Friendswood
Texas
77546
United States
Midtown Psychiatry and TMS Center
Houston
Texas
77007
United States
Peter Ly MD
Houston
Texas
77058
United States
Focus and Balance, LLC
San Antonio
Texas
78229
United States
University of Virginia Health System
Charlottesville
Virginia
22903
United States
Clinical Research Partners, LLC
Petersburg
Virginia
23805
United States
McLean Hospital - Harvard Medical School
Milwaukee
Wisconsin
53227
United States
Derived
Kolitsopoulos F, Ramaker S, Compton S, Broderick S, Orazem J, Bao W, Lokhnygina Y, Chappell P. Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline. J Child Adolesc Psychopharmacol. 2021 Aug;31(6):411-420. doi: 10.1089/cap.2020.0170. Epub 2021 Jul 21.
FG001
Psychotherapy
Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
FG000696 subjectsOut of 696 participants, 1 participant started treatment with another antidepressant alone or along with psychotherapy.
FG001245 subjectsOut of 245 participants, 2 participants started treatment with another antidepressant alone or along with psychotherapy.
COMPLETED
FG000330 subjects
FG001102 subjects
NOT COMPLETED
FG000366 subjects
FG001143 subjects
Type
Comment
Reasons
Withdrew Consent
FG00092 subjects
FG00139 subjects
Patient/Family Moved
FG00028 subjects
FG0013 subjects
Lost to Follow-up
FG000192 subjects
FG00193 subjects
Death
FG0001 subjects
FG0010 subjects
Other
FG00052 subjects
FG0018 subjects
Reason Missing For Discontinuation
FG0001 subjects
FG0010 subjects
Analysis population included all participants in the database who had informed consent.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sertraline
Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.
BG001
Other Antidepressant
Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.
BG002
Psychotherapy
Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000695
BG0013
BG002243
BG003941
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.2± 2.9
BG00114.0± 3.0
BG00211.0± 2.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000405
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00073
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 3
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.
At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000666
OG0013
OG002224
Title
Denominators
Categories
Baseline
ParticipantsOG000666
ParticipantsOG0013
ParticipantsOG002224
Title
Measurements
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 6
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 12
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 18
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 24
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 30
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 36
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Primary
Change From Baseline in Height at Month 3
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 6
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 12
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 18
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 24
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 30
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Height at Month 36
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 3
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 6
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 12
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 18
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 24
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 30
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Weight at Month 36
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 3
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 6
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 12
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 18
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 24
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 30
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Change From Baseline in Body Mass Index (BMI) at Month 36
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Z-score
Baseline, Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure. There were no male participants in reporting arm "Other Antidepressant" at Baseline, hence no data collected and evaluated.
Posted
Count of Participants
Participants
Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 3: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 6: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 12: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 18: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 24: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 30: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 36: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Baseline: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 3: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 3
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 6: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 6
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 12: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 12
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 18: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 18
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 24: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 24
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 30: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 30
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Primary
Number of Participants With Tanner Staging Evaluation at Month 36: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Month 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Secondary
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Count of Participants
Participants
Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Secondary
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Count of Participants
Participants
Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Secondary
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Count of Participants
Participants
No
Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
Secondary
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Count of Participants
Participants
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Secondary
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Units on scale
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
Secondary
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Units on scale
Baseline, Month 3, 6, 12, 18, 24, 30 and 36
ID
Title
Description
OG000
Sertraline
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
OG001
Time Frame
Baseline up to 36 Months
Description
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Sertraline (Baseline)
Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.
0
614
3
614
13
614
EG001
Other Antidepressants (Baseline)
Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.
0
3
0
3
0
3
EG002
Psychotherapy (Baseline)
Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.
0
181
0
181
2
181
EG003
Sertraline (Month 3)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 3 visit.
0
622
27
622
201
622
EG004
Other Antidepressants (Month 3)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 3 visit.
0
19
1
19
4
19
EG005
Psychotherapy (Month 3)
Participants in this group were on psychotherapy only or no treatment at all at Month 3 visit.
0
384
9
384
54
384
EG006
Sertraline (Month 6)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 6 visit.
0
516
19
516
153
516
EG007
Other Antidepressants (Month 6)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 6 visit.
0
48
2
48
10
48
EG008
Psychotherapy (Month 6)
Participants in this group were on psychotherapy only or no treatment at all at Month 6 visit.
0
181
2
181
47
181
EG009
Sertraline (Month 12)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 12 visit.
0
426
11
426
118
426
EG010
Other Antidepressants (Month 12)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 12 visit.
0
80
2
80
18
80
EG011
Psychotherapy (Month 12)
Participants in this group were on psychotherapy only or no treatment at all at Month 12 visit.
0
181
7
181
42
181
EG012
Sertraline (Month 18)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 18 visit.
0
335
11
335
88
335
EG013
Other Antidepressants (Month 18)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 18 visit.
0
84
1
84
20
84
EG014
Psychotherapy (Month 18)
Participants in this group were on psychotherapy only or no treatment at all at Month 18 visit.
0
181
4
181
33
181
EG015
Sertraline (Month 24)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 24 visit.
0
289
6
289
57
289
EG016
Other Antidepressants (Month 24)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 24 visit.
0
83
3
83
19
83
EG017
Psychotherapy (Month 24)
Participants in this group were on psychotherapy only or no treatment at all at Month 24 visit.
0
181
3
181
31
181
EG018
Sertraline (Month 30)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 30 visit.
1
240
2
240
47
240
EG019
Other Antidepressants (Month 30)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 30 visit.
0
85
1
85
12
85
EG020
Psychotherapy (Month 30)
Participants in this group were on psychotherapy only or no treatment at all at Month 30 visit.
0
181
2
181
23
181
EG021
Sertraline (Month 36)
Participants in this group were on sertraline only or sertraline and any other treatment at Month 36 visit.
0
207
4
207
28
207
EG022
Other Antidepressants (Month 36)
Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 36 visit.
0
73
4
73
6
73
EG023
Psychotherapy (Month 36)
Participants in this group were on psychotherapy only or no treatment at all at Month 36 visit.
0
181
2
181
29
181
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Drug ineffective
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0003 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG0031 affected622 at risk
EG0040 affected19 at risk
EG0050 affected384 at risk
EG0060 affected516 at risk
EG0070 affected48 at risk
EG0080 affected181 at risk
EG0090 affected426 at risk
EG0100 affected80 at risk
EG0110 affected181 at risk
EG0120 affected335 at risk
EG0130 affected84 at risk
EG0140 affected181 at risk
EG0150 affected289 at risk
EG0160 affected83 at risk
EG0170 affected181 at risk
EG0180 affected240 at risk
EG0190 affected85 at risk
EG0200 affected181 at risk
EG0210 affected207 at risk
EG0220 affected73 at risk
EG0230 affected181 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Post concussion syndrome
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Liver function test increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anticholinergic syndrome
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Serotonin syndrome
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Aggression
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anger
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Depression
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Homicidal ideation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Self-injurious ideation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Suicidal behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Syncope
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hostility
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Seizure
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0021 affected181 at risk
EG0039 affected622 at risk
EG0040 affected19 at risk
EG0053 affected384 at risk
EG00611 affected516 at risk
EG0071 affected48 at risk
EG0085 affected181 at risk
EG0095 affected426 at risk
EG0101 affected80 at risk
EG0113 affected181 at risk
EG0123 affected335 at risk
EG0131 affected84 at risk
EG0142 affected181 at risk
EG0154 affected289 at risk
EG0161 affected83 at risk
EG0172 affected181 at risk
EG0183 affected240 at risk
EG0190 affected85 at risk
EG0201 affected181 at risk
EG0212 affected207 at risk
EG0220 affected73 at risk
EG0230 affected181 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Fatigue
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0002 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Weight increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v23.0
Non-systematic Assessment
EG0002 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0003 affected614 at risk
EG0010 affected3 at risk
EG0021 affected181 at risk
EG003
Hostility
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0004 affected614 at risk
EG0010 affected3 at risk
EG0021 affected181 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Irritability
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Albright's disease
Congenital, familial and genetic disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Vision blurred
Eye disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Thirst
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Ear infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Impetigo
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Influenza
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Intentional product misuse
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Weight decreased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Akathisia
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Headache
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Aggression
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Apathy
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Blunted affect
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Compulsions
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Depression
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dermatillomania
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Enuresis
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Frustration tolerance decreased
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Impulsive behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Major depression
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Social avoidant behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Stress
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Tachyphrenia
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Tic
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Trichotillomania
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Violence-related symptom
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pyrexia
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Food allergy
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Croup infectious
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Syncope
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Tremor
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Obsessive-compulsive disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Obsessive-compulsive symptom
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Oppositional defiant disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Self-injurious ideation
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Thinking abnormal
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Drug ineffective
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Treatment noncompliance
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Spondylolysis
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Migraine
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sedation
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Seizure
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Antisocial behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Communication disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Emotional distress
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Purging
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Breast disorder
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Fight in school
Social circumstances
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Feeling abnormal
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Feeling jittery
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Influenza like illness
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Mononucleosis syndrome
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Defiant behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Disinhibition
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Learning disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Obsessive thoughts
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Precocious puberty
Endocrine disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Chest pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Sleep terror
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Attention-seeking behaviour
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Eye infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Hallucinations, mixed
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected614 at risk
EG0010 affected3 at risk
EG0020 affected181 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000460
OG00135
OG002159
Title
Denominators
Categories
Title
Measurements
OG000-0.64± 2.2
OG001-0.65± 1.0
OG002-0.16± 1.9
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000367
OG00157
OG002138
Title
Denominators
Categories
Title
Measurements
OG000-0.72± 2.3
OG001-0.22± 1.4
OG002-0.27± 2.4
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000290
OG00170
OG002138
Title
Denominators
Categories
Title
Measurements
OG000-0.57± 1.9
OG001-0.65± 2.2
OG002-0.22± 2.8
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000247
OG00170
OG002134
Title
Denominators
Categories
Title
Measurements
OG000-0.44± 2.2
OG001-1.08± 1.7
OG002-0.18± 3.4
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000209
OG00163
OG002141
Title
Denominators
Categories
Title
Measurements
OG000-0.74± 2.1
OG001-0.61± 2.4
OG002-0.18± 4.2
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000193
OG00156
OG002154
Title
Denominators
Categories
Title
Measurements
OG000-0.25± 2.9
OG001-0.13± 3.6
OG002-0.59± 2.6
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000686
OG0013
OG002237
Title
Denominators
Categories
Baseline
ParticipantsOG000686
ParticipantsOG0013
ParticipantsOG002237
Title
Measurements
OG00062.93± 11.3
OG00157.67± 5.5
OG00259.27± 13.0
Change at Week 3
ParticipantsOG000539
ParticipantsOG0012
ParticipantsOG002170
Title
Measurements
OG000
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000467
OG00135
OG002166
Title
Denominators
Categories
Title
Measurements
OG000-2.53± 8.8
OG001-1.54± 8.8
OG002-2.74± 8.7
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000370
OG00158
OG002140
Title
Denominators
Categories
Title
Measurements
OG000-3.12± 9.1
OG001-1.97± 8.3
OG002-2.81± 9.0
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000290
OG00169
OG002140
Title
Denominators
Categories
Title
Measurements
OG000-2.40± 9.2
OG001-1.57± 9.9
OG002-3.13± 8.3
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000248
OG00166
OG002133
Title
Denominators
Categories
Title
Measurements
OG000-3.37± 10.0
OG001-3.14± 9.0
OG002-4.16± 9.5
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000200
OG00159
OG002135
Title
Denominators
Categories
Title
Measurements
OG000-3.60± 11.2
OG001-4.39± 8.7
OG002-4.53± 10.2
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000184
OG00154
OG002141
Title
Denominators
Categories
Title
Measurements
OG000-3.96± 12.1
OG001-3.87± 10.4
OG002-4.62± 10.9
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000692
OG0013
OG002238
Title
Denominators
Categories
Baseline
ParticipantsOG000692
ParticipantsOG0013
ParticipantsOG002238
Title
Measurements
OG00065.15± 12.0
OG00158.67± 4.0
OG00261.88± 12.6
Change at Week 3
ParticipantsOG000544
ParticipantsOG0012
ParticipantsOG002171
Title
Measurements
OG000
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000472
OG00136
OG002167
Title
Denominators
Categories
Title
Measurements
OG000-4.06± 9.4
OG001-3.14± 9.7
OG002-3.62± 8.9
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000373
OG00159
OG002140
Title
Denominators
Categories
Title
Measurements
OG000-5.42± 10.1
OG001-2.44± 8.2
OG002-5.01± 9.5
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000294
OG00171
OG002140
Title
Denominators
Categories
Title
Measurements
OG000-5.21± 9.9
OG001-3.59± 9.9
OG002-4.48± 9.2
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000252
OG00168
OG002133
Title
Denominators
Categories
Title
Measurements
OG000-6.21± 11.2
OG001-5.78± 8.8
OG002-6.05± 9.9
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000204
OG00161
OG002136
Title
Denominators
Categories
Title
Measurements
OG000-6.92± 10.8
OG001-5.23± 10.0
OG002-6.53± 10.4
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000188
OG00155
OG002142
Title
Denominators
Categories
Title
Measurements
OG000-7.44± 11.1
OG001-7.24± 10.6
OG002-6.22± 11.2
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000693
OG0013
OG002243
Title
Denominators
Categories
Baseline
ParticipantsOG000693
ParticipantsOG0013
ParticipantsOG002243
Title
Measurements
OG0000.31± 1.1
OG0010.76± 1.4
OG0020.32± 1.1
Change at Month 3
ParticipantsOG000554
ParticipantsOG0013
ParticipantsOG002174
Title
Measurements
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000478
OG00136
OG002170
Title
Denominators
Categories
Title
Measurements
OG000-0.02± 0.3
OG0010.07± 0.4
OG0020.00± 0.4
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000381
OG00159
OG002144
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.4
OG0010.06± 0.5
OG002-0.04± 0.4
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000305
OG00174
OG002145
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.5
OG0010.00± 0.5
OG002-0.02± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000263
OG00170
OG002138
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.5
OG001-0.02± 0.6
OG002-0.02± 0.5
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000218
OG00166
OG002148
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.7
OG001-0.10± 0.6
OG0020.00± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000203
OG00162
OG002160
Title
Denominators
Categories
Title
Measurements
OG0000.00± 0.7
OG001-0.04± 0.7
OG002-0.02± 0.9
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000693
OG0013
OG002243
Title
Denominators
Categories
Baseline
ParticipantsOG000693
ParticipantsOG0013
ParticipantsOG002243
Title
Measurements
OG0000.58± 1.2
OG0010.88± 0.7
OG0020.42± 1.0
Change at Month 3
ParticipantsOG000554
ParticipantsOG0013
ParticipantsOG002173
Title
Measurements
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000478
OG00136
OG002170
Title
Denominators
Categories
Title
Measurements
OG0000.03± 0.3
OG0010.01± 0.3
OG002-0.05± 0.3
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000382
OG00159
OG002144
Title
Denominators
Categories
Title
Measurements
OG0000.10± 0.4
OG0010.06± 0.5
OG0020.00± 0.4
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000305
OG00174
OG002145
Title
Denominators
Categories
Title
Measurements
OG0000.14± 0.5
OG0010.07± 0.6
OG002-0.01± 0.5
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000263
OG00170
OG002138
Title
Denominators
Categories
Title
Measurements
OG0000.16± 0.5
OG0010.15± 0.6
OG0020.00± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000218
OG00166
OG002148
Title
Denominators
Categories
Title
Measurements
OG0000.16± 0.6
OG0010.11± 0.6
OG0020.04± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000203
OG00162
OG002162
Title
Denominators
Categories
Title
Measurements
OG0000.17± 0.6
OG0010.17± 0.7
OG0020.02± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000693
OG0013
OG002243
Title
Denominators
Categories
Baseline
ParticipantsOG000693
ParticipantsOG0013
ParticipantsOG002243
Title
Measurements
OG0000.48± 1.3
OG0010.79± 0.4
OG0020.27± 1.3
Change at Month 3
ParticipantsOG000554
ParticipantsOG0013
ParticipantsOG002173
Title
Measurements
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000478
OG00136
OG002170
Title
Denominators
Categories
Title
Measurements
OG0000.04± 0.4
OG001-0.03± 0.4
OG002-0.06± 0.4
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000381
OG00159
OG002144
Title
Denominators
Categories
Title
Measurements
OG0000.13± 0.5
OG0010.06± 0.6
OG0020.04± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000305
OG00174
OG002145
Title
Denominators
Categories
Title
Measurements
OG0000.18± 0.6
OG0010.07± 0.8
OG002-0.04± 0.6
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000263
OG00170
OG002138
Title
Denominators
Categories
Title
Measurements
OG0000.17± 0.7
OG0010.20± 0.9
OG002-0.01± 0.7
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000218
OG00166
OG002148
Title
Denominators
Categories
Title
Measurements
OG0000.16± 0.8
OG0010.15± 0.8
OG0020.03± 0.7
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000203
OG00162
OG002160
Title
Denominators
Categories
Title
Measurements
OG0000.17± 0.8
OG0010.21± 0.9
OG0020.01± 0.7
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000288
OG0010
OG002113
Title
Denominators
Categories
Title
Measurements
Stage 1
OG000122
OG00258
Stage 2
OG00053
OG00220
Stage 3
OG00045
OG00217
Stage 4
OG00053
OG00215
Stage 5
OG00015
OG0023
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000230
OG0011
OG00280
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00094
OG0011
OG00242
Stage 2
OG00040
OG0010
OG00210
Stage 3
OG00043
OG0010
OG00214
Stage 4
OG00045
OG0010
OG00211
Stage 5
OG0008
OG0010
OG0023
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000203
OG00114
OG00277
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00075
OG0016
OG00236
Stage 2
OG00044
OG0012
OG00211
Stage 3
OG00034
OG0013
OG00214
Stage 4
OG00043
OG0012
OG00214
Stage 5
OG0007
OG0011
OG0022
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000164
OG00124
OG00269
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00055
OG0017
OG00230
Stage 2
OG00037
OG0012
OG00211
Stage 3
OG00026
OG0015
OG00212
Stage 4
OG00036
OG0018
OG00212
Stage 5
OG00010
OG0012
OG0024
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000136
OG00133
OG00257
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00039
OG0019
OG00220
Stage 2
OG00031
OG0015
OG00211
Stage 3
OG00019
OG0016
OG00212
Stage 4
OG00033
OG0017
OG0029
Stage 5
OG00014
OG0016
OG0025
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000112
OG00134
OG00262
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00032
OG0017
OG00213
Stage 2
OG00027
OG0019
OG00212
Stage 3
OG00017
OG0016
OG00214
Stage 4
OG00022
OG0016
OG00216
Stage 5
OG00014
OG0016
OG0027
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG00086
OG00133
OG00264
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00023
OG0015
OG00210
Stage 2
OG00018
OG0017
OG0028
Stage 3
OG00016
OG0015
OG00219
Stage 4
OG00015
OG0016
OG00219
Stage 5
OG00014
OG00110
OG0028
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG00084
OG00134
OG00275
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00018
OG0016
OG0027
Stage 2
OG00018
OG0014
OG00212
Stage 3
OG00014
OG00110
OG00215
Stage 4
OG00022
OG0014
OG00225
Stage 5
OG00012
OG00110
OG00216
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000401
OG0013
OG002130
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00081
OG0011
OG00239
Stage 2
OG00040
OG0010
OG00221
Stage 3
OG00061
OG0010
OG00225
Stage 4
OG000146
OG0011
OG00228
Stage 5
OG00073
OG0011
OG00217
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000323
OG0012
OG00294
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00059
OG0011
OG00230
Stage 2
OG00037
OG0010
OG00213
Stage 3
OG00047
OG0010
OG00214
Stage 4
OG000108
OG0010
OG00224
Stage 5
OG00072
OG0011
OG00213
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000275
OG00122
OG00291
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00043
OG0011
OG00222
Stage 2
OG00031
OG0014
OG00213
Stage 3
OG00046
OG0012
OG00218
Stage 4
OG00090
OG00110
OG00218
Stage 5
OG00065
OG0015
OG00220
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000218
OG00135
OG00275
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00027
OG0015
OG0029
Stage 2
OG00027
OG0012
OG00215
Stage 3
OG00031
OG0015
OG00212
Stage 4
OG00071
OG00111
OG00224
Stage 5
OG00062
OG00112
OG00215
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000169
OG00140
OG00288
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00017
OG0014
OG0029
Stage 2
OG00014
OG0012
OG00214
Stage 3
OG00022
OG0012
OG00213
Stage 4
OG00057
OG00114
OG00231
Stage 5
OG00059
OG00118
OG00221
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000151
OG00137
OG00276
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00013
OG0012
OG0028
Stage 2
OG00015
OG0013
OG00210
Stage 3
OG00016
OG0011
OG00213
Stage 4
OG00049
OG00111
OG00224
Stage 5
OG00058
OG00120
OG00221
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000132
OG00133
OG00284
Title
Denominators
Categories
Title
Measurements
Stage 1
OG00010
OG0011
OG0023
Stage 2
OG00015
OG0012
OG0029
Stage 3
OG00015
OG0011
OG0028
Stage 4
OG00034
OG0018
OG00229
Stage 5
OG00058
OG00121
OG00235
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000120
OG00130
OG00288
Title
Denominators
Categories
Title
Measurements
Stage 1
OG0009
OG0010
OG0022
Stage 2
OG0009
OG0012
OG0029
Stage 3
OG0009
OG0017
OG0028
Stage 4
OG00032
OG0017
OG00225
Stage 5
OG00061
OG00114
OG00244
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000556
OG00173
OG002176
Title
Denominators
Categories
Month 3
ParticipantsOG000556
ParticipantsOG0013
ParticipantsOG002176
Title
Measurements
Very Much Improved
OG00077
OG0010
OG00217
Much Improved
OG000223
OG0010
OG00251
Minimally Improved
OG000151
OG0011
OG00269
Not Changed
OG00063
OG0011
OG00229
Minimally Worse
OG00020
OG0010
OG0023
Much Worse
OG00021
OG0010
OG0025
Very Much Worse
OG0001
OG0011
OG0022
Month 6
ParticipantsOG000478
ParticipantsOG00134
ParticipantsOG002167
Title
Measurements
Very Much Improved
OG000
Month 12
ParticipantsOG000382
ParticipantsOG00157
ParticipantsOG002141
Title
Measurements
Very Much Improved
OG000
Month 18
ParticipantsOG000304
ParticipantsOG00173
ParticipantsOG002139
Title
Measurements
Very Much Improved
OG000
Month 24
ParticipantsOG000262
ParticipantsOG00170
ParticipantsOG002130
Title
Measurements
Very Much Improved
OG000
Month 30
ParticipantsOG000214
ParticipantsOG00164
ParticipantsOG002143
Title
Measurements
Very Much Improved
OG000
Month 36
ParticipantsOG000203
ParticipantsOG00164
ParticipantsOG002154
Title
Measurements
Very Much Improved
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000546
OG00165
OG00296
Title
Denominators
Categories
Month 3
ParticipantsOG000546
ParticipantsOG0012
ParticipantsOG00296
Title
Measurements
Very High
OG000274
OG0010
OG00225
High
OG000123
OG0010
OG00218
Above Average
OG00040
OG0010
OG00218
Average
OG00069
OG0012
OG00230
Low
OG00022
OG0010
OG0023
Very Low
OG00010
OG0010
OG0022
Extremely Low
OG0008
OG0010
OG0020
Month 6
ParticipantsOG000468
ParticipantsOG00129
ParticipantsOG00295
Title
Measurements
Very High
OG000
Month 12
ParticipantsOG000367
ParticipantsOG00152
ParticipantsOG00274
Title
Measurements
Very High
OG000
Month 18
ParticipantsOG000298
ParticipantsOG00164
ParticipantsOG00269
Title
Measurements
Very High
OG000
Month 24
ParticipantsOG000250
ParticipantsOG00165
ParticipantsOG00260
Title
Measurements
Very High
OG000
Month 30
ParticipantsOG000210
ParticipantsOG00159
ParticipantsOG00257
Title
Measurements
Very High
OG000
Month 36
ParticipantsOG000197
ParticipantsOG00156
ParticipantsOG00258
Title
Measurements
Very High
OG000
OG001
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000544
OG00167
OG002130
Title
Denominators
Categories
Responders at Month 3
ParticipantsOG000544
ParticipantsOG0012
ParticipantsOG002130
Title
Measurements
OG000296
OG0011
OG00255
Responders at Month 6
ParticipantsOG000470
ParticipantsOG00130
ParticipantsOG002120
Title
Measurements
OG000
Responders at Month 12
ParticipantsOG000372
ParticipantsOG00153
ParticipantsOG00291
Title
Measurements
OG000
Responders at Month 18
ParticipantsOG000300
ParticipantsOG00165
ParticipantsOG00287
Title
Measurements
OG000
Responders at Month 24
ParticipantsOG000255
ParticipantsOG00167
ParticipantsOG00275
Title
Measurements
OG000
Responders at Month 30
ParticipantsOG000212
ParticipantsOG00162
ParticipantsOG00279
Title
Measurements
OG000
Responders at Month 36
ParticipantsOG000198
ParticipantsOG00160
ParticipantsOG00285
Title
Measurements
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000692
OG00174
OG002243
Title
Denominators
Categories
Baseline
ParticipantsOG000692
ParticipantsOG0013
ParticipantsOG002243
Title
Measurements
Normal, Not Mentally ill
OG00021
OG0010
OG00229
Borderline Mentally ill
OG00028
OG0010
OG00217
Mildly Mentally ill
OG000138
OG0010
OG00257
Moderately Mentally ill
OG000377
OG0013
OG002107
Markedly Mentally ill
OG000116
OG0010
OG00231
Severely Mentally ill
OG00012
OG0010
OG0022
Among the Most Extremely Mentally ill
OG0000
OG0010
OG0020
Month 3
ParticipantsOG000556
ParticipantsOG0013
ParticipantsOG002178
Title
Measurements
Normal, Not Mentally ill
OG000
Month 6
ParticipantsOG000479
ParticipantsOG00136
ParticipantsOG002172
Title
Measurements
Normal, Not Mentally ill
OG000
Month 12
ParticipantsOG000383
ParticipantsOG00159
ParticipantsOG002146
Title
Measurements
Normal, Not Mentally ill
OG000
Month 18
ParticipantsOG000304
ParticipantsOG00174
ParticipantsOG002149
Title
Measurements
Normal, Not Mentally ill
OG000
Month 24
ParticipantsOG000263
ParticipantsOG00171
ParticipantsOG002139
Title
Measurements
Normal, Not Mentally ill
OG000
Month 30
ParticipantsOG000218
ParticipantsOG00166
ParticipantsOG002148
Title
Measurements
Normal, Not Mentally ill
OG000
Month 36
ParticipantsOG000204
ParticipantsOG00164
ParticipantsOG002163
Title
Measurements
Normal, Not Mentally ill
OG000
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Units
Counts
Participants
OG000691
OG00174
OG002243
Title
Denominators
Categories
Baseline
ParticipantsOG000691
ParticipantsOG0013
ParticipantsOG002243
Title
Measurements
OG00055.80± 10.0
OG00156.67± 5.8
OG00259.86± 10.9
Change at Month 3
ParticipantsOG000554
ParticipantsOG0013
ParticipantsOG002178
Title
Measurements
OG000
Change at Month 6
ParticipantsOG000478
ParticipantsOG00136
ParticipantsOG002171
Title
Measurements
OG000
Change at Month 12
ParticipantsOG000382
ParticipantsOG00158
ParticipantsOG002146
Title
Measurements
OG000
Change at Month 18
ParticipantsOG000303
ParticipantsOG00174
ParticipantsOG002149
Title
Measurements
OG000
Change at Month 24
ParticipantsOG000262
ParticipantsOG00171
ParticipantsOG002139
Title
Measurements
OG000
Change at Month 30
ParticipantsOG000218
ParticipantsOG00166
ParticipantsOG002147
Title
Measurements
OG000
Change at Month 36
ParticipantsOG000204
ParticipantsOG00164
ParticipantsOG002163
Title
Measurements
OG000
Other Antidepressants
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
OG002
Psychotherapy
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.