Status:
COMPLETED
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Lead Sponsor:
Sanofi
Conditions:
Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- MAJOR INCLUSION CRITERIA:
- Must experience sleep disturbances at least 3 nights/week, based on historical data
- Must meet the diagnostic requirements for Major Depressive Disorder
- Must have QIDS-SR16 score between 6 and 15
- Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
- Age 21-64, inclusive
- 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.
- Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.
- MAJOR EXCLUSION CRITERIA:
- Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
- History of a suicide attempt or suicidal ideation.
- History of mania, manic episode or bipolar disease.
- Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
- Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
- Any abnormal pre-study laboratory values that require clinical intervention
- Prior failure to respond to escitalopram therapy for depression
- Current depressive episode requiring inpatient hospitalization.
- Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
- History of drug addiction, alcoholism, or drug abuse.
- A positive urine drug screen for medication that would interfere with the assessment of the study medication.
- Known allergy to zolpidem, escitalopram or any of their excipients
- History of sleep apnea
- History of myasthenia gravis
- The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
- Pregnant or breastfeeding
- Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00296179
Start Date
February 1 2006
Last Update
July 28 2008
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