At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 560 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 3 Doses of Lu AA21004 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 560 participants across 48 sites in 15 countries.
Detailed Summary
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Czechia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, South Africa, South Korea, Taiwan, Ukraine, United Kingdom
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionJul 2009
Study CompletionAug 2009
TodayJul 2026
First PostedAug 15, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.9 years ago
Interventions
Vortioxetinedrug
Encapsulated immediate-release vortioxetine tablets
Placebodrug
Vortioxetine placebo-matching capsules