At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 602 enrolled
Drug / intervention
vortioxetine (Lu AA21004) +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, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD)
In Brief
A Phase 2 clinical trial evaluating vortioxetine (Lu AA21004), Duloxetine, and 1 other intervention for Depressive Disorder, Major. Completed, enrolled 602 participants across 92 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesBulgaria, Finland, Germany, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedMar 28, 2012
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago
Interventions
vortioxetine (Lu AA21004)drug
Lu AA21004 capsules
Duloxetinedrug
Duloxetine capsules
Placebodrug
Placebo matching capsules