Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
- Conditions
- InsomniaGeneralized Anxiety Disorder
- Interventions
- Registration Number
- NCT00235508
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Eszopiclone (Lunesta) Escitalopram oxalate 10 mg at bedtime 2 Eszopiclone (Lunesta) Eszopiclone 3 mg at bedtime
- Primary Outcome Measures
Name Time Method The change from baseline in subjective sleep latency averaged over the double-blind treatment period. 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in subjective total sleep time averaged over the double blind treatment period. 8 weeks