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To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolpidem tartrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Patient-reported TST |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period |
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MAJOR INCLUSION CRITERIA:
MAJOR EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis Diener | Sanofi | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21208597 | Derived | Fava M, Asnis GM, Shrivastava RK, Lydiard B, Bastani B, Sheehan DV, Roth T. Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial. J Clin Psychiatry. 2011 Jul;72(7):914-28. doi: 10.4088/JCP.09m05571gry. Epub 2010 Dec 28. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D001523 |
| Mental Disorders |