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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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| 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: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | PM_L_0166 |
| Study First Received: | February 23, 2006 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00296179 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Sleep Initiation and Maintenance Disorders Zolpidem Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Dyssomnias Sleep Disorders Depressive Disorder, Major |
Depressive Disorder Pharmacologic Actions Sleep Disorders, Intrinsic Mental Disorders Therapeutic Uses GABA Agonists Hypnotics and Sedatives Mood Disorders GABA Agents Central Nervous System Agents |