CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 535 enrolled
Drug / intervention
Vortioxetine (Lu AA21004)drug
Likely dose
Vortioxetine (Lu AA21004) 10 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/NCT00694304
NCT00694304Phase 3Completed
CompareCT.gov

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

H. Lundbeck A/S·interventional·Posted Jun 10, 2008·Updated Apr 1, 2014

In Brief

A Phase 3 clinical trial evaluating Vortioxetine (Lu AA21004) for Major Depressive Disorder. Completed, enrolled 535 participants.

Detailed Summary

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.1 years ago

Interventions

Vortioxetine (Lu AA21004)drug

2.5, 5, or 10 mg/day; tablets; orally