NCT00616655

Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Detailed description

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	eszopiclone	SEP-225441 (eszopiclone) total daily dose of 1.5 mg
DRUG	eszopiclone	SEP-225441 (eszopiclone) total daily dose of 0.9 mg
DRUG	Placebo	Placebo total daily dose 0.9 mg

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-02-15
• Last updated: 2016-04-08
• Results posted: 2015-08-21

Locations

57 sites across 1 country: United States