Eszopiclone Treatment & Cortisol Responsivity
Information source: Butler Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: eszopiclone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Butler Hospital Official(s) and/or principal investigator(s): Linda Carpenter, MD, Principal Investigator, Affiliation: Butler Hospital
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 assess cortisol reactivity before and after long-term
(6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone
would result in a significant reduction in plasma cortisol response to the DEX/CRH test
following treatment of insomnia with standard dose of eszopiclone.
Clinical Details
Official title: Eszopiclone Treatment & Cortisol Response to HPA Axis Tests
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)
Detailed description:
see above
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Mild to Moderate Insomnia
Exclusion Criteria:
- 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.
Locations and Contacts
Butler Hospital, Providence, Rhode Island 02906, United States
Additional Information
Starting date: May 2007
Last updated: November 3, 2014
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