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 Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study Comparing the Efficacy and Safety of Lu AA21004 Versus Placebo in Acute Treatment of Adults With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine and Placebo for Major Depressive Disorder. Completed, enrolled 600 participants across 33 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, Mexico, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedMay 2008
Primary CompletionNov 2008
TodayJul 2026
First PostedMay 6, 2008
Enrollment StartApr 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.2 years ago
Interventions
Vortioxetinedrug
Encapsulated immediate-release tablets.
Placebodrug
Vortioxetine placebo-matching capsules.