Clinical trial NCT00296179: Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 372
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy: Patient-reported TST
Secondary outcomes:
measure: Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Phyllis Diener
role: STUDY_DIRECTOR
References:
citation: 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.