NCT00730691

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

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 781 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of 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, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks. 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. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Placebo-matching capsules
DRUG	Vortioxetine	Encapsulated vortioxetine immediate release tablets
DRUG	Duloxetine	Overencapsulated duloxetine capsules

Timeline

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

Locations

66 sites across 1 country: United States