At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 469 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 Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 15 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine and Placebo for Depressive Disorder, Major. Completed, enrolled 469 participants across 61 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionMay 2012
Study CompletionJun 2012
TodayJul 2026
First PostedAug 11, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.9 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate release tablets
Placebodrug
Vortioxetine placebo-matching capsules