Eszopiclone Treatment & Cortisol Responsivity

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00889200
First received: April 23, 2009
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: eszopiclone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Eszopiclone Treatment & Cortisol Response to HPA Axis Tests

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • change in cortisol response to the Dex/CRH test [ Time Frame: 8 weeks-pre/post drug ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label Eszopiclone
Standard dosing of drug for 6 weeks for insomnia
Drug: eszopiclone
6 weeks standard oral therapy

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889200

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Sunovion
Investigators
Principal Investigator: Linda Carpenter, MD Butler Hospital
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00889200     History of Changes
Other Study ID Numbers: 0608-002
Study First Received: April 23, 2009
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydrocortisone
Eszopiclone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014