Status:
COMPLETED
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Lead Sponsor:
Sanofi
Conditions:
Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE4
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 (Lex...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00296790
Start Date
February 1 2006
End Date
February 1 2007
Last Update
October 12 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807