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| Sponsor: | Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
|
A: Experimental
Eszopiclone 3 mg QD
|
Drug: Eszopiclone
Eszopiclone 3 mg QD
|
|
B: Placebo Comparator
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.
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: | Sepracor Inc ( Eszopiclone Medical Director ) |
| Study ID Numbers: | 190-052 |
| Study First Received: | August 23, 2006 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368030 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Insomnia related to major depressive disorder. |
|
Sleep Initiation and Maintenance Disorders Depression Disease Nervous System Diseases Dyssomnias Sleep Disorders Depressive Disorder, Major |
Depressive Disorder Behavioral Symptoms Sleep Disorders, Intrinsic Pathologic Processes Mental Disorders Mood Disorders |