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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00296179 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia |
Drug: zolpidem tartrate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Comparison of Zolpidem Tartrate Extended-Release vs. Placebo in Treatment of Insomnia Associated With Newly Diagnosed Major Depressive Disorder(MDD) or Untreated MDD Relapse, When Used Concomitantly With Escitalopram |
| Estimated Enrollment: | 372 |
| Study Start Date: | February 2006 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
MAJOR INCLUSION CRITERIA:
MAJOR EXCLUSION CRITERIA:
Contacts and Locations
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00296179 History of Changes |
| Other Study ID Numbers: | PM_L_0166 |
| Study First Received: | February 23, 2006 |
| Last Updated: | July 25, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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Depressive Disorder, Major Sleep Initiation and Maintenance Disorders Depressive Disorder Mood Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Zolpidem Hypnotics and Sedatives |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |