NCT00731120

Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Detailed description

Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period. Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine	Encapsulated vortioxetine immediate-release tablets
DRUG	Placebo	Vortioxetine placebo-matching capsules

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2008-08-08
• Last updated: 2013-12-18
• Results posted: 2013-12-18

Locations

40 sites across 1 country: United States