At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 481 enrolled
Drug / intervention
vilazodone +1 moredrug
Likely dose
vilazodone 40 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 Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone 40 mg qd and Evaluating Genetic Biomarkers Associated With Treatment Response in Patients With Major Depressive Disorder (MDD)
In Brief
A Phase 3 clinical trial evaluating vilazodone and placebo for Major Depressive Disorder. Completed, enrolled 481 participants across 9 sites.
Detailed Summary
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMay 2008
Primary CompletionFeb 2009
Study CompletionMar 2009
TodayJul 2026
First PostedMay 23, 2008
Enrollment StartMar 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.1 years ago
Interventions
vilazodonedrug
titration to 40 mg tablets qd (once a day) for 8 weeks
placebodrug
placebo