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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
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Tucson, Arizona, United States | |
| Peoria, Arizona, United States | |
| United States, Arkansas | |
| Fayetteville, Arkansas, United States | |
| United States, California | |
| Irvine, California, United States | |
| Garden Grove, California, United States | |
| Northridge, California, United States | |
| San Diego, California, United States | |
| Riverside, California, United States | |
| United States, Colorado | |
| Wheat Ridge, Colorado, United States | |
| United States, Connecticut | |
| New Britian, Connecticut, United States | |
| United States, Florida | |
| St. Petersburg, Florida, United States | |
| North Miami, Florida, United States | |
| Miami Beach, Florida, United States | |
| Miami, Florida, United States | |
| Jacksonville, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Smyrna, Georgia, United States | |
| Decatur, Georgia, United States | |
| Augusta, Georgia, United States | |
| United States, Idaho | |
| Boise, Idaho, United States | |
| United States, Kansas | |
| Overland Park, Kansas, United States | |
| United States, Maryland | |
| Rockville, Maryland, United States | |
| United States, Massachusetts | |
| Cambridge, Massachusetts, United States | |
| Brighton, Massachusetts, United States | |
| Watertown, Massachusetts, United States | |
| Braintree, Massachusetts, United States | |
| Boston, Massachusetts, United States | |
| Brockton, Massachusetts, United States | |
| United States, Michigan | |
| Farmington Hills, Michigan, United States | |
| United States, Missouri | |
| St Louis, Missouri, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, New Jersey | |
| Clementon, New Jersey, United States | |
| Morestown, New Jersey, United States | |
| United States, New York | |
| Bronx, New York, United States | |
| Lawerence, New York, United States | |
| New York, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States | |
| United States, Ohio | |
| Beachwood, Ohio, United States | |
| Dayton, Ohio, United States | |
| Cincinatti, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| Salem, Oregon, United States | |
| Portland, Oregon, United States | |
| Springfield, Oregon, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Emmaus, Pennsylvania, United States | |
| Scotland, Pennsylvania, United States | |
| Conshohocken, Pennsylvania, United States | |
| United States, South Carolina | |
| Anderson, South Carolina, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| Selmer, Tennessee, United States | |
| Madison, Tennessee, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| Austin, Texas, United States | |
| Wichita Falls, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Spokane, Washington, United States | |
| Lakewood, Washington, United States | |
| Seatle, Washington, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
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 |