CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 enrolled
Drug / intervention
Vortioxetine (Lu AA21004)drug
Likely dose
Vortioxetine (Lu AA21004) 20 mgfrom 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.

Search/NCT01323478
NCT01323478Phase 3Completed
CompareCT.gov

A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder

H. Lundbeck A/S·interventional·Posted Mar 25, 2011·Updated Feb 11, 2014

In Brief

A Phase 3 clinical trial evaluating Vortioxetine (Lu AA21004) for Major Depressive Disorder. Completed, enrolled 71 participants.

Detailed Summary

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartApr 1, 2011
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.3 years ago

Interventions

Vortioxetine (Lu AA21004)drug

15 or 20 mg/day; tablets; orally