CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 766 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Vortioxetine (Lu AA21004) 2.5 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/NCT00635219
NCT00635219Phase 3Completed
CompareCT.gov

A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder

H. Lundbeck A/S·interventional·Posted Mar 13, 2008·Updated Feb 11, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, Vortioxetine (Lu AA21004), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 766 participants.

Detailed Summary

The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2008
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.3 years ago

Interventions

Placebodrug

capsules; daily; orally

Vortioxetine (Lu AA21004)drug

2.5 mg/day; encapsulated tablets; orally

Vortioxetine (Lu AA21004)drug

5 mg/day; encapsulated tablets; orally

Vortioxetine (Lu AA21004)drug

10 mg/day; encapsulated tablets; orally

Duloxetinedrug

60 mg/day; encapsulated capsules; orally