Status:
COMPLETED
Eszopiclone Treatment & Cortisol Responsivity
Lead Sponsor:
Butler Hospital
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to a...
Detailed Description
see above
Eligibility Criteria
Inclusion
- Mild to Moderate Insomnia
Exclusion
- Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders)
- Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks)
- Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone)
- History of a significant adverse reaction to eszopiclone
- Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months
- Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures
- Limited mental competency and the inability to give informed, voluntary, written consent to participate.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00889200
Start Date
May 1 2007
End Date
August 1 2009
Last Update
September 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Butler Hospital
Providence, Rhode Island, United States, 02906