Insomnia
Conditions
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Patient-reported TST | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period | — |
Outcome results
None listed