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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
zolpidem tartrate
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    February 23, 2006
    Last Updated
    July 25, 2008
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00296179
    Brief Title
    Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    372 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    zolpidem tartrate
    Primary Outcome Measure Information:
    Title
    Efficacy: Patient-reported TST
    Secondary Outcome Measure Information:
    Title
    Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Phyllis Diener
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21208597
    Citation
    Fava M, Asnis GM, Shrivastava RK, Lydiard B, Bastani B, Sheehan DV, Roth T. Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial. J Clin Psychiatry. 2011 Jul;72(7):914-28. doi: 10.4088/JCP.09m05571gry. Epub 2010 Dec 28.
    Results Reference
    derived

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

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