NCT00811252

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

Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	capsules; daily; orally
DRUG	Vortioxetine (Lu AA21004)	encapsulated tablets; daily; orally
DRUG	Duloxetine	encapsulated tablets; daily; orally

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2008-12-18
• Last updated: 2014-01-29
• Results posted: 2013-12-18