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Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296179
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : July 28, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Insomnia Drug: zolpidem tartrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2006
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy: Patient-reported TST

Secondary Outcome Measures :
  1. Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Must experience sleep disturbances at least 3 nights/week, based on historical data
  2. Must meet the diagnostic requirements for Major Depressive Disorder
  3. Must have QIDS-SR16 score between 6 and 15
  4. Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
  5. Age 21-64, inclusive
  6. Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization.
  7. Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.


  1. Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
  2. History of a suicide attempt or suicidal ideation.
  3. History of mania, manic episode or bipolar disease.
  4. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
  5. Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
  6. Any abnormal pre-study laboratory values that require clinical intervention
  7. Prior failure to respond to escitalopram therapy for depression
  8. Current depressive episode requiring inpatient hospitalization.
  9. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
  10. History of drug addiction, alcoholism, or drug abuse.
  11. A positive urine drug screen for medication that would interfere with the assessment of the study medication.
  12. Known allergy to zolpidem, escitalopram or any of their excipients
  13. History of sleep apnea
  14. History of myasthenia gravis
  15. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
  16. Pregnant or breastfeeding
  17. Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296179

Sponsors and Collaborators
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Study Director: Phyllis Diener Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00296179    
Other Study ID Numbers: PM_L_0166
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action