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| Sponsor: | Sunovion |
|---|---|
| Information provided by: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00368030 |
Purpose
The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia Depressive Disorder, Major |
Drug: Eszopiclone Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Depression Response to Eszopiclone in Adults With Major Depressive Disorder (DREAMDD): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 8-Week, Safety & Efficacy Study of Eszopiclone 3 mg Compared to Placebo in Subjects With Insomnia Related to MDD Acronym: DREAMDD |
| Enrollment: | 545 |
| Study Start Date: | January 2004 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Eszopiclone 3 mg QD
|
Drug: Eszopiclone
Eszopiclone 3 mg QD
Other Name: Lunesta, (S)-Zopliclone
|
|
Placebo Comparator: B
Placebo tablet
|
Other: Placebo
Placebo tablet
|
This study is a double-blind, randomized, placebo-controlled, parallel group study. The study consists of two groups of subjects with major depression treated for ten weeks with a common antidepressant regimen, 20-40 mg of fluoxetine hydrochloride per day; and randomized to receive (in addition) either eszopiclone 3 mg or placebo for eight 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.
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 65 Study Locations
More Information
| Responsible Party: | Eszopiclone Medical Director, Sunovion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00368030 History of Changes |
| Other Study ID Numbers: | 190-052 |
| Study First Received: | August 23, 2006 |
| Last Updated: | January 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Insomnia related to major depressive disorder. |
|
Depressive Disorder Depression Depressive Disorder, Major Sleep Initiation and Maintenance Disorders Mood Disorders Mental Disorders Behavioral Symptoms Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |