Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
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| ClinicalTrials.gov Identifier: NCT00296179 |
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Recruitment Status :
Completed
First Posted : February 24, 2006
Last Update Posted : July 28, 2008
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Sponsor:
Sanofi
Information provided by:
Sanofi
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Insomnia | Drug: zolpidem tartrate | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 372 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 Start Date : | February 2006 |
| Actual Primary Completion Date : | June 2007 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
Primary Outcome Measures :
- Efficacy: Patient-reported TST
Secondary Outcome Measures :
- Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
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| Ages Eligible for Study: | 21 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296179
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Phyllis Diener | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00296179 History of Changes |
| Other Study ID Numbers: |
PM_L_0166 |
| First Posted: | February 24, 2006 Key Record Dates |
| Last Update Posted: | July 28, 2008 |
| Last Verified: | July 2008 |
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives |
Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |