At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 836 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 Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine for Major Depressive Disorder. Completed, enrolled 836 participants across 92 sites in 17 countries.
Detailed Summary
The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, Serbia, South Africa, South Korea, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJul 2008
Primary CompletionJul 2010
Study CompletionAug 2010
TodayJul 2026
First PostedJul 2, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate-release tablets