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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00296179
First received: February 23, 2006
Last updated: July 25, 2008
Last verified: July 2008

February 23, 2006
July 25, 2008
February 2006
June 2007   (final data collection date for primary outcome measure)
Efficacy: Patient-reported TST
Not Provided
Complete list of historical versions of study NCT00296179 on ClinicalTrials.gov Archive Site
Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
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Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insomnia
Drug: zolpidem tartrate
Not Provided
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. Epub 2010 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
Not Provided
June 2007   (final data collection date for primary outcome measure)

MAJOR INCLUSION CRITERIA:

  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.

MAJOR EXCLUSION CRITERIA:

  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.
Both
21 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00296179
PM_L_0166
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Phyllis Diener Sanofi
Sanofi
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP