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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

Page last updated: August 23, 2015

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