At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 607 enrolled
Drug / intervention
Placebo +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 Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo, Vortioxetine (Lu AA21004), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 607 participants.
Detailed Summary
The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedJun 2010
Primary CompletionSep 2011
TodayJul 2026
First PostedJun 10, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago
Interventions
Placebodrug
capsules, daily, orally
Vortioxetine (Lu AA21004)drug
encapsulated tablets, daily, orally
Duloxetinedrug
encapsulated capsules, daily, orally