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| Sponsor: | Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00235508 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia Generalized Anxiety Disorder |
Drug: Eszopiclone (Lunesta) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder. |
| Enrollment: | 420 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Escitalopram oxalate 10 mg at bedtime
|
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
|
|
2: Active Comparator
Eszopiclone 3 mg at bedtime
|
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Show 64 Study Locations
More Information
| Responsible Party: | Sepracor Inc. ( Executive Medical Director, Clinical Research ) |
| Study ID Numbers: | 190-902 |
| Study First Received: | October 6, 2005 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00235508 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Insomnia Anxiety Generalized Anxiety Disorder |
|
Sleep Initiation and Maintenance Disorders Pathologic Processes Disease Anxiety Disorders Mental Disorders |
Nervous System Diseases Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |