At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 337 enrolled
Drug / intervention
duloxetine +2 moredrug
Likely dose
duloxetine 120 mgfrom 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.
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating duloxetine, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 337 participants across 59 sites in 7 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
CountriesFrance, Germany, Russia, Slovakia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionMar 2011
Study CompletionOct 2011
TodayJul 2026
First PostedFeb 24, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.4 years ago
Interventions
duloxetinedrug
30-120 mg, PO, QD, for up to 38 weeks
Placebodrug
Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks
fluoxetinedrug
10-40 milligram (mg), PO, QD, for up to 38 weeks