At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 639 enrolled
Drug / intervention
Placebo +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 Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo and Vortioxetine (Lu AA21004) for Major Depressive Disorder. Completed, enrolled 639 participants.
Detailed Summary
This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedJan 2008
Primary CompletionSep 2009
Study CompletionOct 2009
TodayJul 2026
First PostedJan 17, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.5 years ago
Interventions
Placebodrug
capsules, daily, orally
Vortioxetine (Lu AA21004)drug
encapsulated tablets, daily, orally