NCT00839423

Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	capsules, daily, orally
DRUG	Vortioxetine (Lu AA21004)	encapsulated tablets, daily, orally
DRUG	Venlafaxine XL	capsules, daily, orally

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-08-01
• Completion: 2007-09-01
• First posted: 2009-02-09
• Last updated: 2014-05-13
• Results posted: 2013-12-17