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

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ClinicalTrials.gov Identifier: NCT00296179
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : July 28, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 23, 2006
First Posted Date  ICMJE February 24, 2006
Last Update Posted Date July 28, 2008
Study Start Date  ICMJE February 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
Efficacy: Patient-reported TST
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00296179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE Drug: zolpidem tartrate
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 7, 2006)
372
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00296179
Other Study ID Numbers  ICMJE PM_L_0166
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phyllis Diener Sanofi
PRS Account Sanofi
Verification Date July 2008

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