NCT00635219

Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	capsules; daily; orally
DRUG	Vortioxetine (Lu AA21004)	2.5 mg/day; encapsulated tablets; orally
DRUG	Vortioxetine (Lu AA21004)	5 mg/day; encapsulated tablets; orally
DRUG	Vortioxetine (Lu AA21004)	10 mg/day; encapsulated tablets; orally
DRUG	Duloxetine	60 mg/day; encapsulated capsules; orally

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-03-13
• Last updated: 2014-02-11
• Results posted: 2014-02-11