At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 495 enrolled
Drug / intervention
Vortioxetine (Lu AA21004) +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 Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
In Brief
A Phase 3 clinical trial evaluating Vortioxetine (Lu AA21004) and Agomelatine for Major Depressive Disorder. Completed, enrolled 495 participants.
Detailed Summary
The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartJan 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedDec 8, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.6 years ago
Interventions
Vortioxetine (Lu AA21004)drug
encapsulated tablets, daily, orally
Agomelatinedrug
encapsulated tablets, daily, orally