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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Insomnia

Intervention / Treatment
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* Drug: zolpidem tartrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zolpidem tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Patient-reported TST |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period |  |  |