At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,106 enrolled
Drug / intervention
Vortioxetine +1 moredrug
Likely dose
Not stated in 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, Phase 4, Relapse Prevention Study Evaluating the Efficacy and Safety of Vortioxetine (5, 10 and 20 mg) in Adults With Major Depressive Disorder
In Brief
A Phase 4 clinical trial evaluating Vortioxetine and Placebo for Major Depressive Disorder. Completed, enrolled 1,106 participants across 79 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD who responded to acute treatment with vortioxetine 10 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedFeb 2015
Primary CompletionMar 2019
Study CompletionApr 2019
TodayJul 2026
First PostedFeb 26, 2015
Enrollment StartFeb 10, 2015
Primary CompletionMar 1, 2019
Study CompletionApr 25, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.3 years ago
Interventions
Vortioxetinedrug
Vortioxetine capsules
Placebodrug
Vortioxetine placebo-matching capsules