At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 529 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Vilazodone 15 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, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo and Vilazodone for Major Depressive Disorder. Completed, enrolled 529 participants across 52 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartJul 2013
Primary CompletionMar 2016
Study CompletionOct 2016
TodayJul 2026
First PostedJun 14, 2013
Enrollment StartJul 11, 2013
Primary CompletionMar 17, 2016
Study CompletionOct 5, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.0 years ago
Interventions
Placebodrug
Dose matched placebo tablets, once per day, oral administration.
Vilazodonedrug
Vilazodone tablets, 15 mg per day, oral administration
Vilazodonedrug
Vilazodone tablets, 30 mg once per day, oral administration