Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Study Details
Study Description
Brief Summary
A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Evaluate safety and hypnotic efficacy of zolpidem tartrate extended release vs. placebo in treatment of insomnia associated with Generalized Anxiety Disorder when used concomitantly with escitalopram []
Secondary Outcome Measures
- To show that treating insomnia from beginning of SSRI (Selective Serotonin Reuptake Inhibitor) treatment for anxiety results in improvement in quality of life and possibly greater response to anti-anxiety therapy []
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
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Male or female between the ages of 21and 64 years, inclusive;
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Women must use a medically acceptable form of contraception 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;
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Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
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Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
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Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
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Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
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Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.
EXCLUSION
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History of Post-Traumatic Stress Disorder;
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Concomitant Major Depressive Disorder or Bipolar Disorder;
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Any abnormal pre-study laboratory values that require clinical intervention
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Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
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Pregnant or breastfeeding
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History of drug addiction, alcoholism, or drug abuse
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Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
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A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
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Use of prescription and non-prescription sedative drugs;
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Prior failure to respond to escitalopram therapy for anxiety
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The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
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History of sleep apnea
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History of myasthenia gravis
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Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
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Subject is currently participating in another clinical trial (or within 28 days of screening).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Bridgewater | New Jersey | United States | 08807 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Phyllis Diener, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PM_L_0167