At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 366 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, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine and Placebo for Major Depressive Disorder. Completed, enrolled 366 participants across 32 sites.
Detailed Summary
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder. The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedMay 17, 2011
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago
Interventions
Vortioxetinedrug
Vortioxetine tablets
Placebodrug
Vortioxetine placebo