At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 614 enrolled
Drug / intervention
Vortioxetine +2 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, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine, Duloxetine, and 1 other intervention for Depressive Disorder, Major. Completed, enrolled 614 participants across 56 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
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionMar 2012
TodayJul 2026
First PostedJun 29, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.0 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate release tablets
Duloxetinedrug
Overencapsulated duloxetine delayed-release capsules
Placebodrug
Placebo-matching capsules