At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 453 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.
Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
In Brief
A Phase 3 clinical trial evaluating Placebo, Vortioxetine (Lu AA21004), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 453 participants.
Detailed Summary
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartJan 2009
Primary CompletionFeb 2010
Study CompletionMar 2010
TodayJul 2026
First PostedDec 18, 2008
Enrollment StartJan 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.5 years ago
Interventions
Placebodrug
capsules; daily; orally
Vortioxetine (Lu AA21004)drug
encapsulated tablets; daily; orally
Duloxetinedrug
encapsulated tablets; daily; orally