A Study in Pediatric Participants With Generalized Anxiet... | NCT01226511 | Trialant
NCT01226511
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 5, 2014Estimated
Enrollment
281Actual
Phase
Phase 3
Conditions
Anxiety Neuroses
Anxiety States, Neurotic
Neuroses, Anxiety
Interventions
Duloxetine
Placebo
Countries
United States
Mexico
South Africa
Protocol Section
Identification Module
NCT ID
NCT01226511
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12929
Secondary IDs
ID
Type
Description
Link
F1J-MC-HMGI
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Pediatric Participants With Generalized Anxiety Disorder
Official Title
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2014
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
Jun 2011
Primary Completion Date
Feb 2013Actual
Completion Date
Jun 2013Actual
First Submitted Date
Oct 12, 2010
First Submission Date that Met QC Criteria
Oct 21, 2010
First Posted Date
Oct 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 17, 2014
Results First Submitted that Met QC Criteria
Jan 17, 2014
Results First Posted Date
Mar 5, 2014Estimated
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
Jan 17, 2014
Last Update Posted Date
Mar 5, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
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
The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).
Detailed Description
Not provided
Conditions Module
Conditions
Anxiety Neuroses
Anxiety States, Neurotic
Neuroses, Anxiety
Keywords
Not provided
Design Module
Study Type
Interventional
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
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
281Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Duloxetine
Experimental
30-120 mg flexible dosing once daily for 10 weeks. At the end of the 10 week blinded treatment period, participants may participate in an 18 week extension
Drug: Duloxetine
Placebo
Placebo Comparator
Administered once daily for 10 weeks. At the end of the 10 week blinded treatment period, placebo participants receive duloxetine in the 18 week extension
Drug: Duloxetine
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Duloxetine
Drug
Administered orally
Duloxetine
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.
Baseline, 10 weeks
Secondary Outcomes
Measure
Description
Time Frame
Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD
Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with GAD on clinical exam as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-Kid)
Diagnosis of moderate or greater severity of GAD as determined by the following:
Presence of 4 or more symptoms identified on the generalized anxiety subsection of the Pediatric Anxiety Rating Scale (PARS) symptom checklist at screening and randomization. Two of which are excessive worry and dread or fearful anticipation (nonspecific)
PARS severity score of 15 or more at screening and randomization for symptoms identified on the generalized anxiety subsection of PARS symptom checklist at screening and randomization
Clinical Global Impressions of Severity (CGI-S) rating of 4 or more at screening and randomization
Presence of significant social, academic, and/or familial dysfunction as determined by the Children's Global Assessment Scale (CGAS) score of 60 or less at screening and randomization
Female participants must test negative for pregnancy during screening Furthermore, female participants must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study
Participant's parent/legal representative and participant, if capable, are judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol
Participant's parent/legal representative and participant, if capable, must have a degree of understanding such that they can communicate intelligently with the investigator and study coordinator
Participants must be capable of swallowing study drug whole (without opening the capsule, crushing, dissolving, dividing, et cetera)
Participants must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol
Exclusion Criteria:
Current diagnosis of major depressive disorder (MDD)
Participants for whom the primary focus of treatment is separation anxiety or social phobia (participants with secondary separation anxiety or social phobia are allowed to participate)
Have current primary diagnosis of any DSM-IV-TR Axis I disorder except GAD, or a current secondary DSM-IV-TR Axis 1 disorder that requires any pharmacologic treatment (other than those disorders listed below). Primary is defined as the disorder that is the primary focus of treatment
Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder, as judged by the investigator
Have 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder
Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ECG) result, hypersensitivity to duloxetine, or its active ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C), or a history of any seizure disorder (other than febrile seizures)
Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator
Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening. Participants who require a change to psychotherapy between weeks 1 through 10 will be excluded
Have a weight less than 20 kilograms at any time during the screening period
Female participants who are pregnant, nursing or have recently given birth
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
7 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Strawn JR, Prakash A, Zhang Q, Pangallo BA, Stroud CE, Cai N, Findling RL. A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder. J Am Acad Child Adolesc Psychiatry. 2015 Apr;54(4):283-93. doi: 10.1016/j.jaac.2015.01.008. Epub 2015 Jan 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study had 4 periods: Screening period (1-week), acute treatment period (10-week, double-blind period with flexible duloxetine dosing), extension treatment (18-week period, of which 16 weeks were open-label treatment with flexible duloxetine dosing), and a taper period (2 weeks recommended at discontinuation from study any point after Week 2).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Duloxetine/Duloxetine
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
Baseline, 10 weeks
Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
Baseline, 10 weeks
Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale
Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.
10 weeks
Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.
Baseline, 10 weeks
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Baseline up to 10 weeks
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Baseline up to 10 weeks
Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
10 weeks, 28 weeks
Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
10 weeks, 28 weeks
Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
10 weeks, 28 weeks
Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.
10 weeks, 28 weeks
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
10 weeks up to 28 weeks
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
10 weeks up to 28 weeks
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Smyrna
Georgia
30080
United States
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Libertyville
Illinois
60048
United States
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Lexington
Kentucky
40509
United States
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Troy
Michigan
48083
United States
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Gladstone
Missouri
64118
United States
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Omaha
Nebraska
68198
United States
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Cherry Hill
New Jersey
08002
United States
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New York
New York
10032
United States
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Rochester
New York
14618
United States
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Cincinnati
Ohio
45219
United States
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Cleveland
Ohio
44106
United States
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Oklahoma City
Oklahoma
73103
United States
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Richmond
Virginia
23230
United States
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Bellevue
Washington
98007
United States
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Spokane
Washington
99202
United States
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Insurgentes Cuicuilco
04530
Mexico
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Mexico City
14080
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey
64060
Mexico
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San Luis Potosà City
78200
Mexico
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Zona Centro
37000
Mexico
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Bloemfontein
9301
South Africa
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Cape Town
7530
South Africa
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Pretoria
0042
South Africa
FG001
Placebo/Duloxetine
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
FG000140 subjectsThirty-one (31) participants who discontinued acute treatment did not enter the taper period.
FG001141 subjectsTwenty-six (26) participants who discontinued acute treatment did not enter the taper period.
COMPLETED
FG000108 subjects
FG001110 subjects
NOT COMPLETED
FG00032 subjects
FG00131 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0016 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
Lost to Follow-up
FG0003 subjects
FG0016 subjects
Parent/caregiver decision
FG0005 subjects
FG0017 subjects
Protocol Violation
FG0005 subjects
FG0015 subjects
Withdrawal by Subject
FG00010 subjects
FG0016 subjects
Extension Treatment Period
Type
Comment
Milestone Data
STARTED
FG000108 subjectsNineteen (19) participants who discontinued extension treatment did not enter the taper period.
FG001110 subjectsTwenty-three (23) participants who discontinued extension treatment did not enter the taper period.
COMPLETED
FG00081 subjectsThirty-nine (39) participants who completed extension treatment did not enter the taper period.
FG00183 subjectsThirty-five (35) participants who completed extension treatment did not enter the taper period.
NOT COMPLETED
FG00027 subjects
FG00127 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0018 subjects
Lack of Efficacy
FG0003 subjects
FG001
Taper Period
Type
Comment
Milestone Data
STARTED
FG00051 subjects
FG00157 subjects
COMPLETED
FG00046 subjects
FG00154 subjects
NOT COMPLETED
FG0005 subjects
FG0013 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
Lost to Follow-up
FG0002 subjects
FG001
All randomized participants, excluding 9 participants from 1 site with major quality issues.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Duloxetine/Duloxetine
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
BG001
Placebo/Duloxetine
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000135
BG001137
BG002272
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
7 to 11 years
Title
Measurements
BG00062
BG00166
BG002128
12 to 17 years
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00070
BG00175
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00037
BG00140
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0007
BG0016
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00098
BG00199
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 to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.
Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Units
Counts
Participants
OG000135
OG001133
Title
Denominators
Categories
Title
Measurements
OG000-9.70± 0.502
OG001-7.05± 0.500
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
Least squares (LS) mean difference
-2.65
Standard Error of the Mean
0.700
2-Sided
95
-4.03
-1.27
No
Superiority or Other
Secondary
Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD
Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Number
percentage of participants
Baseline, 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Secondary
Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Secondary
Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Units
Counts
Secondary
Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale
Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.
Randomized participants with at least 1 post-baseline CGI-S score [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Number
percentage of participants
10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Units
Counts
Participants
Secondary
Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.
Randomized participants with a baseline and at least 1 post-baseline [last observation carried forward (LOCF)] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was <5. Nine (9) participants from 1 site with major quality issues were excluded.
Posted
Number
percentage of participants
Baseline up to 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Secondary
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Number
percentage of participants
Baseline up to 10 weeks
ID
Title
Description
OG000
Duloxetine (Acute Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
OG001
Placebo (Acute Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Secondary
Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
10 weeks, 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Secondary
Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms
PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
10 weeks, 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Secondary
Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.
Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
10 weeks, 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
Secondary
Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)
The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.
Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period [last observation carried forward (LOCF)], excluding 9 participants from 1 site with major quality issues.
Posted
Least Squares Mean
Standard Error
units on a scale
10 weeks, 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
Secondary
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Randomized participants with a C-SSRS suicidal ideation score <5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.
Posted
Number
percentage of participants
10 weeks up to 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
Secondary
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.
Posted
Number
percentage of participants
10 weeks up to 28 weeks
ID
Title
Description
OG000
Duloxetine/Duloxetine (Extension Treatment)
Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
OG001
Placebo/Duloxetine (Extension Treatment)
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
Time Frame
Not provided
Description
Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
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
Duloxetine
Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
1
135
106
135
EG001
Placebo
AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
0
137
90
137
EG002
Duloxetine/Duloxetine-Extension Treatment
AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
2
104
73
104
EG003
Placebo/Duloxetine-Extension Treatment
AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
2
106
73
106
EG004
Duloxetine-Taper
AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
1
97
12
97
EG005
Placebo-Taper
AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
1
7
1
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Adenoiditis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected135 at risk
EG0010 events0 affected137 at risk
EG0021 events1 affected104 at risk
EG0030 events0 affected106 at risk
EG0040 events0 affected97 at risk
EG0050 events0 affected7 at risk
Tonsillitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected135 at risk
EG0010 events0 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Self-injurious ideation
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
SAE reported for 1 participant (Duloxetine/Duloxetine group) during the extension treatment period and resolved during the duloxetine-taper period. The SAE was counted in both periods, although it was not new or worsening during the taper period.
EG0001 events1 affected135 at risk
EG0010 events0 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG0030 events0 affected106 at risk
EG0040 events0 affected97 at risk
EG0050 events0 affected7 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0014 events4 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00015 events13 affected135 at risk
EG00110 events9 affected137 at risk
EG0026 events5 affected104 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 events5 affected135 at risk
EG0014 events4 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00010 events9 affected135 at risk
EG0016 events6 affected137 at risk
EG0023 events1 affected104 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00035 events28 affected135 at risk
EG0018 events8 affected137 at risk
EG00210 events10 affected104 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00023 events22 affected135 at risk
EG00110 events10 affected137 at risk
EG0027 events5 affected104 at risk
EG003
Chest pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0010 events0 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Fatigue
General disorders
MedDRA 16.0
Systematic Assessment
EG00011 events11 affected135 at risk
EG0016 events6 affected137 at risk
EG0024 events4 affected104 at risk
EG003
Irritability
General disorders
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG0016 events6 affected137 at risk
EG0024 events4 affected104 at risk
EG003
Pyrexia
General disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected135 at risk
EG0015 events4 affected137 at risk
EG0022 events2 affected104 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG0014 events4 affected137 at risk
EG0022 events2 affected104 at risk
EG003
Ear infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0012 events2 affected137 at risk
EG0023 events3 affected104 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0011 events1 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG0012 events2 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG0013 events3 affected137 at risk
EG0026 events6 affected104 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG00113 events12 affected137 at risk
EG0024 events4 affected104 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0011 events1 affected137 at risk
EG0022 events2 affected104 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0012 events2 affected137 at risk
EG0023 events3 affected104 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0014 events4 affected137 at risk
EG0026 events6 affected104 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected135 at risk
EG0014 events4 affected137 at risk
EG0024 events3 affected104 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0012 events2 affected137 at risk
EG0023 events3 affected104 at risk
EG003
Weight decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0005 events5 affected135 at risk
EG0011 events1 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Weight increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected135 at risk
EG0013 events3 affected137 at risk
EG0022 events2 affected104 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG00021 events20 affected135 at risk
EG0017 events7 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected135 at risk
EG0014 events4 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00010 events10 affected135 at risk
EG0012 events2 affected137 at risk
EG0025 events5 affected104 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00037 events27 affected135 at risk
EG00129 events23 affected137 at risk
EG00217 events13 affected104 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected135 at risk
EG0013 events3 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0012 events2 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Sedation
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00016 events16 affected135 at risk
EG0019 events9 affected137 at risk
EG0024 events3 affected104 at risk
EG003
Tremor
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected135 at risk
EG0011 events1 affected137 at risk
EG0022 events2 affected104 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG00013 events12 affected135 at risk
EG0018 events7 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0011 events1 affected137 at risk
EG0023 events3 affected104 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0003 events2 affected70 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected53 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected135 at risk
EG0010 events0 affected137 at risk
EG0024 events4 affected104 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected135 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG00010 events10 affected135 at risk
EG0013 events3 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 events3 affected135 at risk
EG0012 events1 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected135 at risk
EG0012 events2 affected137 at risk
EG0021 events1 affected104 at risk
EG003
Hot flush
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected135 at risk
EG0011 events1 affected137 at risk
EG0020 events0 affected104 at risk
EG003
Nine (9) randomized participants (5 duloxetine, 4 placebo) from 1 site were excluded from efficacy and safety analyses due to major quality issues at that site.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D001008
Anxiety Disorders
Ancestor Terms
ID
Term
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068736
Duloxetine Hydrochloride
Ancestor Terms
ID
Term
D013876
Thiophenes
D013457
Sulfur Compounds
D009930
Organic Chemicals
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
Lost to Follow-up
FG0004 subjects
FG0013 subjects
Protocol Violation
FG0002 subjects
FG0012 subjects
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
Parent/Caregiver Decision
FG0008 subjects
FG0018 subjects
Sponsor Decision
FG0001 subjects
FG0011 subjects
2 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
Parent/Caregiver Decision
FG0001 subjects
FG0011 subjects
Title
Measurements
BG00073
BG00171
BG002144
145
Male
BG00065
BG00162
BG002127
77
Not Hispanic or Latino
BG00088
BG00188
BG002176
Unknown or Not Reported
BG00010
BG0019
BG00219
13
Asian
Title
Measurements
BG0001
BG0011
BG0022
Black or African American
Title
Measurements
BG0009
BG00110
BG00219
White
Title
Measurements
BG000112
BG001111
BG002223
More than 1 race
Title
Measurements
BG0006
BG0019
BG00215
197
Mexico
Title
Measurements
BG00026
BG00126
BG00252
South Africa
Title
Measurements
BG00011
BG00112
BG00223
Units
Counts
Participants
OG000135
OG001133
Title
Denominators
Categories
Title
Measurements
OG00051± 4.8
OG00137± 4.8
Units
Counts
Participants
OG000135
OG001133
Title
Denominators
Categories
Title
Measurements
OG000-9.15± 0.479
OG001-6.36± 0.477
Participants
OG000135
OG001133
Title
Denominators
Categories
Title
Measurements
OG000-1.93± 0.114
OG001-1.38± 0.113
OG000135
OG001133
Title
Denominators
Categories
Title
Measurements
OG00045
OG00130
OG000123
OG001124
Title
Denominators
Categories
Title
Measurements
OG00017.14± 1.232
OG00112.16± 1.219
Units
Counts
Participants
OG000135
OG001134
Title
Denominators
Categories
Title
Measurements
OG0005.9
OG0015.2
Units
Counts
Participants
OG000135
OG001134
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
Units
Counts
Participants
OG000104
OG001105
Title
Denominators
Categories
Title
Measurements
OG000-3.33± 0.352
OG001-5.15± 0.452
Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.