A Study in the Treatment of Children and Adolescents With... | NCT00849693 | Trialant
NCT00849693
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 19, 2012Estimated
Enrollment
463Actual
Phase
Phase 3
Conditions
Major Depressive Disorder
Interventions
Placebo
fluoxetine
duloxetine
duloxetine
Countries
United States
Argentina
Canada
Mexico
Protocol Section
Identification Module
NCT ID
NCT00849693
Obsolete or Duplicate NCT IDs
NCT00892294
Organization Study
7109
Secondary IDs
ID
Type
Description
Link
F1J-MC-HMCL
Other Identifier
Eli Lilly and Company
Brief Title
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Official Title
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2012
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
Mar 2009
Primary Completion Date
Feb 2011Actual
Completion Date
Sep 2011Actual
First Submitted Date
Feb 23, 2009
First Submission Date that Met QC Criteria
Feb 23, 2009
First Posted Date
Feb 24, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 22, 2012
Results First Submitted that Met QC Criteria
Mar 26, 2012
Results First Posted Date
Apr 19, 2012Estimated
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
Mar 26, 2012
Last Update Posted Date
Apr 19, 2012Estimated
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 assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
Detailed Description
Not provided
Conditions Module
Conditions
Major Depressive Disorder
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
463Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Drug: Placebo
Fluoxetine
Active Comparator
Drug: fluoxetine
Duloxetine 60 mg
Experimental
Drug: duloxetine
Duloxetine 30 mg
Experimental
Drug: duloxetine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Baseline, Week 10
Secondary Outcomes
Measure
Description
Time Frame
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Outpatient, diagnosed with major depressive disorder (MDD) 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 MDD as determined by Children's Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to 40 at screen, and randomization and a Clinical Global Impression of Severity (CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.
Female patients must test negative for pregnancy during screening.
Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.
Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.
Exclusion Criteria:
Children of site personnel directly affiliated with this study and/or their immediate families.
Children of Lilly employees or employees of the designated clinical research organization (CRO) assisting with the conduct of the study.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.
Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment
Have 1 or more first-degree relatives with diagnosed bipolar I disorder.
Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator.
Have a weight less than 20 kilogram (kg) at screening.
Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.
Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening.
Have a history of seizure disorder (other than febrile seizures).
Have a history of electroconvulsive therapy within 1 year of screening.
Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of randomization; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.
Have previously enrolled, completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.
Have a positive urine drug screen for any substances of abuse or excluded medication.
Are taking any excluded medications that cannot be discontinued by screening.
Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients; or have frequent or severe allergic reactions to multiple medications.
Have uncontrolled narrow-angle glaucoma.
Have acute liver injury or severe cirrhosis.
Have a serious or unstable medical illness, psychological condition, or clinically significant laboratory or electrocardiogram (ECG) result that, in the opinion of the investigator, would compromise participation in the study or be likely to lead to hospitalization.
Have abnormal thyroid-stimulating hormone concentration.
Have initiated or discontinued hormone therapy within the previous 3 months.
Female patients who are either pregnant, nursing or have recently given birth.
Need to use thioridazine during the study or within 5 weeks after discontinuation of study drug or need to use pimozide during the study.
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.
Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.
This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase)
Fluoxetine
LY110140
Prozac
duloxetine
Drug
60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Duloxetine 60 mg
LY248686
Cymbalta
duloxetine
Drug
30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Duloxetine 30 mg
LY248686
Cymbalta
Week 10, Week 36
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Baseline, Week 10
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Baseline, Week 10
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Week 10, Week 36
Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Baseline, Week 10
Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Week 10, Week 36
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Columbia Suicide Rating Scale (C-SSRS) captures 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. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).
Baseline through Week 10
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Columbia Suicide Rating Scale (C-SSRS) captures 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. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).
Week 10 through Week 36
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.
Baseline through Week 10
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.
Week 10 through Week 36
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Baseline through Week 10
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Week 10 through Week 36
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.
Dothan
Alabama
36303
United States
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Little Rock
Arkansas
72223
United States
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Carson
California
90746
United States
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Escondido
California
92025
United States
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Imperial
California
92251
United States
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Riverside
California
92506
United States
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San Diego
California
92123
United States
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Aurora
Colorado
80045
United States
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Middletown
Connecticut
06457
United States
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Bradenton
Florida
34208
United States
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Gainesville
Florida
32607
United States
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Hialeah
Florida
33013
United States
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Jacksonville
Florida
32216
United States
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North Miami
Florida
33161
United States
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Tampa
Florida
33613
United States
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West Palm Beach
Florida
33407
United States
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Winter Park
Florida
32789
United States
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Oak Brook
Illinois
60523
United States
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Terre Haute
Indiana
47802
United States
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Wichita
Kansas
67114
United States
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Lake Charles
Louisiana
70601
United States
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Baltimore
Maryland
21208
United States
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Glen Burnie
Maryland
21061
United States
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Rockville
Maryland
20852
United States
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Clinton Twp
Michigan
48038
United States
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Lincoln
Nebraska
68510
United States
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Albuquerque
New Mexico
87109
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
73139
United States
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Salem
Oregon
97301
United States
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Philadelphia
Pennsylvania
19139
United States
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Charleston
South Carolina
29407
United States
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Memphis
Tennessee
38119
United States
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Austin
Texas
78731
United States
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Dalllas
Texas
75235
United States
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Houston
Texas
77008
United States
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Lake Jackson
Texas
77566
United States
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Wharton
Texas
77488
United States
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Richmond
Virginia
23230
United States
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Bellevue
Washington
98007
United States
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Seattle
Washington
98104
United States
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West Allis
Wisconsin
53227
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.
Buenos Aires
C1058AAJ
Argentina
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Kelowna
British Columbia
V1Y 1Z9
Canada
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Parry Sound
Ontario
P2A 3A4
Canada
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Toronto
Ontario
M6J 3S3
Canada
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Aguascalientes
20217
Mexico
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Guadalajara
44630
Mexico
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León
37000
Mexico
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Mexico City
7810
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.
Mérida
97000
Mexico
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Monterrey
64710
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.
Morelia
58260
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.
Tlalnepantla
53160
Mexico
Emslie GJ, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):170-9. doi: 10.1089/cap.2013.0096. Epub 2014 May 9.
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
FG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
FG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
FG000108 subjects
FG001116 subjects
FG002117 subjects
FG003122 subjects
COMPLETED
FG00075 subjects2 didn't enter extension phase.
FG00181 subjects1 didn't enter extension phase
FG00284 subjects
FG00385 subjects3 didn't enter extension phase
NOT COMPLETED
FG00033 subjects
FG00135 subjects
FG00233 subjects
FG00337 subjects
Type
Comment
Reasons
Adverse Event
FG00012 subjects
FG0017 subjects
FG0026 subjects
FG0034 subjects
Lost to Follow-up
FG0005 subjects
FG0018 subjects
FG00211 subjects
FG0039 subjects
Protocol Violation
FG0001 subjects
FG0015 subjects
FG0022 subjects
FG0036 subjects
Withdrawal by Subject
FG0005 subjects
FG0015 subjects
FG0023 subjects
FG0038 subjects
Parent or caregiver decision
FG0007 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
Physician Decision
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Lack of Efficacy
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
Extension Phase
Type
Comment
Milestone Data
STARTED
FG00073 subjects
FG00180 subjects
FG00284 subjects
FG00382 subjects
COMPLETED
FG00043 subjects
FG00150 subjects
FG00249 subjects
FG00344 subjects
NOT COMPLETED
FG00030 subjects
FG00130 subjects
FG00235 subjects
FG00338 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0016 subjects
FG0023 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
BG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
BG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
BG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000108
BG001116
BG002117
BG003122
BG004463
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
BG00012.92± 2.925
BG00112.86± 2.904
BG00213.04± 3.205
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00060
BG00147
BG002
Race/Ethnicity, Customized
Number
Participant
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG00015
BG00123
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00087
BG00186
BG002
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00059.3± 10.87
BG001
CDRS-R Subscale Scores
CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Mood
Title
Measurements
BG00016.6± 3.69
BG001
Clinical Global Impressions of Severity (CGI-Severity) score
CGI-Severity score evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0004.6± 0.65
BG001
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 Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Participants with both a baseline and at least one post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Units
Counts
Participants
OG000105
OG001117
Title
Denominators
Categories
Title
Measurements
OG000-23.9± 1.30
OG001-21.6± 1.27
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
0.193
95
No
Superiority or Other
Secondary
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Participants with value during treatment phase and at least one post-Week 10 value.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 10, Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Secondary
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Participants with both a baseline and at least one post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG001
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
OG002
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Secondary
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Participants with both a baseline and at least one post-baseline values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG002
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
OG003
Placebo
Secondary
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Participants with value during treatment phase and at least one post-Week 10 value.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 10, Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Secondary
Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Participants with both a baseline and at least one post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG002
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
OG003
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Secondary
Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Participants with value during treatment phase and at least one post-Week 10 value.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 10, Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
Secondary
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Columbia Suicide Rating Scale (C-SSRS) captures 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. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).
Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Posted
Number
participants
Baseline through Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG002
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
Secondary
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Columbia Suicide Rating Scale (C-SSRS) captures 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. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).
Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Posted
Number
participants
Week 10 through Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Secondary
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.
Participants with normal ALT value (ALT<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.
Posted
Number
participants
Baseline through Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG002
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
OG003
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Secondary
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.
Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.
Posted
Number
participants
Week 10 through Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.
Posted
Number
percentage of participants
Baseline through Week 10
ID
Title
Description
OG000
Duloxetine 60mg
Duloxetine 60mg orally, once daily for 10 weeks
OG001
Duloxetine 30mg
Duloxetine 30mg orally, once daily for 10 weeks
OG002
Fluoxetine 20mg
Fluoxetine 20mg orally, once daily for 10 weeks
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.
Posted
Number
percentage of participants
Week 10 through Week 36
ID
Title
Description
OG000
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
OG001
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Time Frame
Not provided
Description
Not provided
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 60 mg - Acute
Duloxetine 60 mg, orally, once daily for 10 weeks
4
108
76
108
EG001
Duloxetine 30 mg - Acute
Duloxetine 30 mg, orally, once daily for 10 weeks
2
116
66
116
EG002
Fluoxetine 20 mg - Acute
Fluoxetine 20 mg, orally, once daily for 10 weeks
6
117
69
117
EG003
Placebo - Acute
Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
2
122
71
122
EG004
Duloxetine 60 mg - Extension
Duloxetine 60-120 mg , orally, once daily for 6 months
3
73
49
73
EG005
Duloxetine 30 mg - Extension
Duloxetine 60-120 mg , orally, once daily for 6 months
One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section]).
2
81
46
81
EG006
Fluoxetine 20 mg - Extension
Fluoxetine 20-40 mg, orally, once daily for 6 months
1
84
45
84
EG007
Placebo/Duloxetine - Extension
Duloxetine 60-120 mg , orally, once daily for 6 months
4
82
52
82
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected122 at risk
EG0041 events1 affected73 at risk
EG0050 events0 affected81 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected82 at risk
Tuberculosis of peripheral lymph nodes
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0021 events1 affected117 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected116 at risk
EG0021 events1 affected117 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0021 events1 affected117 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0021 events1 affected117 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0022 events2 affected117 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Homicidal ideation
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Self injurious behaviour
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected116 at risk
EG0022 events2 affected117 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 events3 affected108 at risk
EG0012 events2 affected116 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected122 at risk
EG0044 events4 affected73 at risk
EG0051 events1 affected81 at risk
EG0061 events1 affected84 at risk
EG0070 events0 affected82 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG00014 events13 affected108 at risk
EG00110 events10 affected116 at risk
EG00210 events10 affected117 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0004 events4 affected108 at risk
EG0019 events9 affected116 at risk
EG0023 events3 affected117 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG00020 events18 affected108 at risk
EG00122 events21 affected116 at risk
EG00212 events11 affected117 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0006 events5 affected108 at risk
EG0018 events7 affected116 at risk
EG0022 events2 affected117 at risk
EG003
Fatigue
General disorders
MedDRA 14.0
Systematic Assessment
EG0005 events5 affected108 at risk
EG0017 events6 affected116 at risk
EG0024 events4 affected117 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected108 at risk
EG0014 events3 affected116 at risk
EG0020 events0 affected117 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0003 events3 affected108 at risk
EG0014 events4 affected116 at risk
EG0028 events7 affected117 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected108 at risk
EG0017 events6 affected116 at risk
EG0023 events3 affected117 at risk
EG003
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected116 at risk
EG0023 events3 affected117 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0006 events6 affected108 at risk
EG00110 events10 affected116 at risk
EG0026 events6 affected117 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0009 events9 affected108 at risk
EG00111 events10 affected116 at risk
EG0025 events5 affected117 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG00022 events19 affected108 at risk
EG00127 events20 affected116 at risk
EG00226 events22 affected117 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG00011 events11 affected108 at risk
EG0013 events3 affected116 at risk
EG0024 events4 affected117 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected108 at risk
EG0014 events4 affected116 at risk
EG0022 events2 affected117 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 events3 affected108 at risk
EG0012 events2 affected116 at risk
EG0026 events6 affected117 at risk
EG003
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
D003865
Depressive Disorder, Major
Ancestor Terms
ID
Term
D003866
Depressive Disorder
D019964
Mood Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D005473
Fluoxetine
D000068736
Duloxetine Hydrochloride
Ancestor Terms
ID
Term
D011437
Propylamines
D000588
Amines
D009930
Organic Chemicals
D013876
Thiophenes
D013457
Sulfur Compounds
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
7 subjects
Lost to Follow-up
FG0007 subjects
FG0015 subjects
FG0026 subjects
FG0036 subjects
Protocol Violation
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
Withdrawal by Subject
FG0006 subjects
FG0019 subjects
FG00210 subjects
FG00315 subjects
Parent or caregiver decision
FG0009 subjects
FG0014 subjects
FG00210 subjects
FG0035 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
Sponsor decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Lack of Efficacy
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
13.09
± 2.895
BG00412.98± 2.977
61
BG00369
BG004237
Male
BG00048
BG00169
BG00256
BG00353
BG004226
16
BG00319
BG00473
Asian
Title
Measurements
BG0000
BG0011
BG0021
BG0031
BG0043
Black or African American
Title
Measurements
BG00027
BG00121
BG00221
BG00324
BG00493
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
White
Title
Measurements
BG00054
BG00161
BG00267
BG00362
BG004244
Multiracial
Title
Measurements
BG0006
BG0016
BG0029
BG00313
BG00434
Not Provided
Title
Measurements
BG0006
BG0013
BG0023
BG0033
BG00415
93
BG00398
BG004364
Mexico
Title
Measurements
BG00016
BG00125
BG00216
BG00317
BG00474
Canada
Title
Measurements
BG0005
BG0015
BG0027
BG0037
BG00424
Argentina
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
59.8
± 11.00
BG00257.9± 10.11
BG00358.2± 9.35
BG00458.8± 10.33
16.4
± 3.64
BG00216.0± 3.52
BG00316.0± 3.38
BG00416.2± 3.55
Somatic
Title
Measurements
BG00019.6± 4.58
BG00119.7± 4.87
BG00219.3± 4.60
BG00319.5± 4.28
BG00419.5± 4.57
Subjective
Title
Measurements
BG00010.1± 3.51
BG00110.6± 3.60
BG00210.0± 3.35
BG00310.0± 2.79
BG00410.2± 3.32
Behavior
Title
Measurements
BG00013.0± 3.04
BG00113.1± 3.19
BG00212.7± 3.12
BG00312.6± 3.14
BG00412.8± 3.12
4.6
± 0.65
BG0024.6± 0.59
BG0034.5± 0.63
BG0044.6± 0.63
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Units
Counts
Participants
OG00070
OG00178
OG00280
OG00379
Title
Denominators
Categories
Title
Measurements
OG000-7.8± 1.04
OG001-7.4± 1.23
OG002-10.0± 1.17
OG003-9.0± 1.84
Units
Counts
Participants
OG000114
OG001112
OG002117
Title
Denominators
Categories
Title
Measurements
OG000-24.6± 1.29
OG001-22.6± 1.27
OG002-21.6± 1.27
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Units
Counts
Participants
OG000105
OG001114
OG002112
OG003117
Title
Denominators
Categories
Mood
Title
Measurements
OG000-7.1± 0.44
OG001-7.2± 0.44
OG002-6.6± 0.43
OG003-6.4± 0.43
Somatic
Title
Measurements
OG000-7.6± 0.48
OG001-7.9± 0.48
OG002-7.1± 0.47
OG003
Subjective
Title
Measurements
OG000-3.6± 0.26
OG001-4.0± 0.26
OG002-3.5± 0.26
OG003
Behavior
Title
Measurements
OG000-5.8± 0.36
OG001-5.6± 0.36
OG002-5.6± 0.35
OG003
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Units
Counts
Participants
OG00070
OG00178
OG00280
OG00379
Title
Denominators
Categories
Mood
Title
Measurements
OG000-1.9± 0.43
OG001-1.9± 0.42
OG002-2.4± 0.44
OG003-2.3± 0.59
Somatic
Title
Measurements
OG000-2.8± 0.41
OG001-2.4± 0.52
OG002-4.0± 0.47
OG003
Subjective
Title
Measurements
OG000-1.2± 0.25
OG001-1.3± 0.19
OG002-1.5± 0.21
OG003
Behavior
Title
Measurements
OG000-2.1± 0.30
OG001-1.8± 0.32
OG002-2.7± 0.28
OG003
Units
Counts
Participants
OG000105
OG001114
OG002112
OG003117
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 0.12
OG001-1.5± 0.12
OG002-1.4± 0.11
OG003-1.4± 0.11
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Units
Counts
Participants
OG00069
OG00178
OG00281
OG00379
Title
Denominators
Categories
Title
Measurements
OG000-1.1± 0.13
OG001-0.9± 0.16
OG002-1.3± 0.12
OG003-1.0± 0.13
OG003
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Units
Counts
Participants
OG000105
OG001115
OG002112
OG003117
Title
Denominators
Categories
Suicidal Ideation
Title
Measurements
OG00016
OG00111
OG00213
OG00315
Suicidal Behavior
Title
Measurements
OG0000
OG0010
OG0021
OG003
Treatment Emergent Suicidal Ideation
Title
Measurements
OG0007
OG0016
OG0029
OG003
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Units
Counts
Participants
OG00071
OG00178
OG00280
OG00379
Title
Denominators
Categories
Suicidal Ideation
Title
Measurements
OG0006
OG00112
OG0028
OG0038
Suicidal Behavior
Title
Measurements
OG0002
OG0013
OG0020
OG003
Treatment Emergent Suicidal Ideation
Title
Measurements
OG0005
OG0018
OG0027
OG003
Units
Counts
Participants
OG00095
OG00198
OG002102
OG003100
Title
Denominators
Categories
ALT≥3 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG0030
ALT≥5 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT≥10 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT≥3 x ULN and Total Bilirubin≥2 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
Units
Counts
Participants
OG00069
OG00169
OG00277
OG00373
Title
Denominators
Categories
ALT≥3 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG0030
ALT≥5 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT≥10 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT≥3 x ULN and Total Bilirubin≥2 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
Units
Counts
Participants
OG000108
OG001116
OG002117
OG003122
Title
Denominators
Categories
Diastolic BP Increase (N=93, 100, 99, 110)
Title
Measurements
OG00011.8
OG0017.0
OG00210.1
OG0034.5
Systolic BP Increase (N=88, 95, 93, 98)
Title
Measurements
OG0009.1
OG00112.6
OG00212.9
OG003
Pulse Decrease (N=100, 108, 108, 112)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pulse Increase (N=105, 114, 112, 117)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight Decrease (N=105, 114, 112, 117)
Title
Measurements
OG00013.3
OG0018.8
OG00211.6
OG003
OG002
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
OG003
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase