Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
This study has been completed.
Information provided by:
First received: February 23, 2006
Last updated: October 11, 2007
Last verified: October 2007
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).
Drug: zolpidem tartrate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||21 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00296790
|Bridgewater, New Jersey, United States, 08807 |
No publications provided
ClinicalTrials.gov processed this record on March 30, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 23, 2006
||October 11, 2007
||United States: Food and Drug Administration