NCT01564862

Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.

Detailed description

Lu AA21004 is under codevelopment by Takeda Global Research \& Development Center, Inc. and H. Lundbeck A/S for the treatment of MDD. This study will consist of a screening period within 10 days of the Baseline Visit followed by an 8-week double-blind treatment period and a one-week taper down period.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	vortioxetine (Lu AA21004)	Lu AA21004 capsules
DRUG	Duloxetine	Duloxetine capsules
DRUG	Placebo	Placebo matching capsules

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-03-28
• Last updated: 2015-02-05
• Results posted: 2015-02-05

Locations

92 sites across 7 countries: United States, Bulgaria, Finland, Germany, Poland, Russia, Ukraine