Generalized Anxiety Disorder, Insomnia
Conditions
Keywords
Insomnia, Anxiety, Generalized Anxiety Disorder
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.
Interventions
DRUGEszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Subjects, between the ages of 18 and 64 years inclusive * Subjects with Generalized Anxiety Disorder (GAD) * Subjects with insomnia related to GAD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in subjective sleep latency averaged over the double-blind treatment period. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in subjective total sleep time averaged over the double blind treatment period. | 8 weeks |
Countries
United States
Outcome results
None listed