At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 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 Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging 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 Depressive Disorder, Major. Completed, enrolled 600 participants across 70 sites in 16 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesCroatia, Finland, Germany, Hong Kong, India, Japan, Latvia, Malaysia, Philippines, Poland, Romania, Russia, Serbia, South Korea, Taiwan, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionMar 2012
Study CompletionApr 2012
TodayJul 2026
First PostedDec 7, 2010
Enrollment StartNov 1, 2010
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.6 years ago
Interventions
Vortioxetinedrug
Vortioxetine tablets
Placebodrug
Vortioxetine placebo-matching tablets