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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00296790
First received: February 23, 2006
Last updated: October 11, 2007
Last verified: October 2007

February 23, 2006
October 11, 2007
February 2006
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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
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Complete list of historical versions of study NCT00296790 on ClinicalTrials.gov Archive Site
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
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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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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).

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insomnia
Drug: zolpidem tartrate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
February 2007
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INCLUSION CRITERIA:

  1. Male or female between the ages of 21and 64 years, inclusive;
  2. 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;
  3. Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
  4. Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
  5. Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
  6. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
  7. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.

EXCLUSION

  1. History of Post-Traumatic Stress Disorder;
  2. Concomitant Major Depressive Disorder or Bipolar Disorder;
  3. Any abnormal pre-study laboratory values that require clinical intervention
  4. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
  5. Pregnant or breastfeeding
  6. History of drug addiction, alcoholism, or drug abuse
  7. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
  8. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
  9. Use of prescription and non-prescription sedative drugs;
  10. Prior failure to respond to escitalopram therapy for anxiety
  11. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
  12. History of sleep apnea
  13. History of myasthenia gravis
  14. Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
  15. Subject is currently participating in another clinical trial (or within 28 days of screening).
Both
21 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296790
PM_L_0167
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Sanofi
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Study Director: Phyllis Diener Sanofi
Sanofi
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP