At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 611 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 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses 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 Major Depressive Disorder. Completed, enrolled 611 participants across 38 sites.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedMay 2008
Primary CompletionNov 2008
Study CompletionDec 2008
TodayJul 2026
First PostedMay 6, 2008
Enrollment StartApr 1, 2008
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.2 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate-release tablets
Duloxetinedrug
Duloxetine capsules
Placebodrug
Placebo-matching capsules