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Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 4
Locations
United States
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

INCLUSION CRITERIA: Male or female between the ages of 21and 64 years, inclusive; 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; Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders; Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A) Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry. EXCLUSION History of Post-Traumatic Stress Disorder; Concomitant Major Depressive Disorder or Bipolar Disorder; Any abnormal pre-study laboratory values that require clinical intervention Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month. Pregnant or breastfeeding History of drug addiction, alcoholism, or drug abuse Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic. Use of prescription and non-prescription sedative drugs; Prior failure to respond to escitalopram therapy for anxiety The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy. History of sleep apnea History of myasthenia gravis Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients Subject is currently participating in another clinical trial (or within 28 days of screening).

Sites / Locations

  • Sanofi-Aventis

Outcomes

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

Full Information

First Posted
February 23, 2006
Last Updated
October 11, 2007
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00296790
Brief Title
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. 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).

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
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Male or female between the ages of 21and 64 years, inclusive; 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; Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders; Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A) Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry. EXCLUSION History of Post-Traumatic Stress Disorder; Concomitant Major Depressive Disorder or Bipolar Disorder; Any abnormal pre-study laboratory values that require clinical intervention Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month. Pregnant or breastfeeding History of drug addiction, alcoholism, or drug abuse Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic. Use of prescription and non-prescription sedative drugs; Prior failure to respond to escitalopram therapy for anxiety The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy. History of sleep apnea History of myasthenia gravis Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients Subject is currently participating in another clinical trial (or within 28 days of screening).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Diener
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

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Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

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