Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Sumitomo Pharma

Status and phase: Completed; Phase 4

Conditions: Insomnia; Generalized Anxiety Disorder

Treatments: Drug: Eszopiclone (Lunesta)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00235508

190-902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Subjects, between the ages of 18 and 64 years inclusive
• Subjects with Generalized Anxiety Disorder (GAD)
• Subjects with insomnia related to GAD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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420 participants in 2 patient groups

1

Active Comparator group

Description:

Escitalopram oxalate 10 mg at bedtime

Treatment:

Drug: Eszopiclone (Lunesta)

2

Active Comparator group

Description:

Eszopiclone 3 mg at bedtime

Treatment:

Drug: Eszopiclone (Lunesta)