NCT00235508

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

Detailed description

An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. 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

• Insomnia
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Eszopiclone (Lunesta)	Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2005-10-10
• Last updated: 2012-02-22

Locations

64 sites across 1 country: United States