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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Escitalopram oxalate 10 mg at bedtime |
|
| 2 | Active Comparator | Eszopiclone 3 mg at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone (Lunesta) | Drug | Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in subjective sleep latency averaged over the double-blind treatment period. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in subjective total sleep time averaged over the double blind treatment period. | 8 weeks |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21208574 | Result | Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. J Clin Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2. | |
| 18458207 |
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| Mesa |
| Arizona |
| United States |
| Scottsdale | Arizona | United States |
| Irvine | California | United States |
| La Mesa | California | United States |
| National City | California | United States |
| Oceanside | California | United States |
| Orange | California | United States |
| Pasadena | California | United States |
| Redlands | California | United States |
| Riverside | California | United States |
| San Diego | California | United States |
| Farmington | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Coral Springs | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| Pembroke Pines | Florida | United States |
| St. Petersburg | Florida | United States |
| Atlanta | Georgia | United States |
| Augusta | Georgia | United States |
| Smyrna | Georgia | United States |
| Northfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Owensboro | Kentucky | United States |
| Baltimore | Maryland | United States |
| Rockville | Maryland | United States |
| Braintree | Massachusetts | United States |
| Brighton | Massachusetts | United States |
| Brockton | Massachusetts | United States |
| Cambridge | Massachusetts | United States |
| Watertown | Massachusetts | United States |
| St Louis | Missouri | United States |
| Kenilworth | New Jersey | United States |
| Piscataway | New Jersey | United States |
| Brooklyn | New York | United States |
| Lawrence | New York | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Beachwood | Ohio | United States |
| Cincinnati | Ohio | United States |
| Dayton | Ohio | United States |
| Middleburg Heights | Ohio | United States |
| Eugene | Oregon | United States |
| Portland | Oregon | United States |
| Salem | Oregon | United States |
| Moon Township | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Scotland | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Memphis | Tennessee | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| Richardson | Texas | United States |
| San Antonio | Texas | United States |
| Wichita Falls | Texas | United States |
| Falls Church | Virginia | United States |
| Richmond | Virginia | United States |
| Middleton | Wisconsin | United States |
| Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62. doi: 10.1001/archpsyc.65.5.551. |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D011725 | Pyridines |
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