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
  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 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy: Patient-reported TST

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

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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296179

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 01, 2014