At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,075 enrolled
Drug / intervention
Vortioxetinedrug
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 Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine for Depressive Disorder, Major. Completed, enrolled 1,075 participants.
Detailed Summary
The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedJun 29, 2010
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.0 years ago
Interventions
Vortioxetinedrug
Vortioxetine tablets