Conditions: Generalized Anxiety Disorder
Keywords: Anxiety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 456
Healthy volunteers: no

Brief 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.

Arms:
arm 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg arm 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg arm 3: Placebo total daily dose 0.9 mg

Interventions: intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
Intervention descriptions: intervention 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg intervention 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg intervention 3: Placebo total daily dose 0.9 mg

Protocol document: