NCT00734071

An Efficacy and Safety Study 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 Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

Detailed description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine. The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 5 mg * Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

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: 2009-03-01
• First posted: 2008-08-13
• Last updated: 2013-12-18
• Results posted: 2013-12-18

Locations

33 sites across 1 country: United States