CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 463 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
fluoxetine 20 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00849693
NCT00849693Phase 3Completed
CompareCT.gov

A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder

Eli Lilly and Company·interventional·Posted Feb 24, 2009·Updated Apr 19, 2012

In Brief

A Phase 3 clinical trial evaluating Placebo, fluoxetine, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 463 participants across 56 sites in 4 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesArgentina, Canada, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2009
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.4 years ago

Interventions

Placebodrug

Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)

fluoxetinedrug

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)

duloxetinedrug

60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)

duloxetinedrug

30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)