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Eszopiclone Treatment & Cortisol Responsivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889200
First Posted: April 28, 2009
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sunovion
Information provided by (Responsible Party):
Butler Hospital
  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: None (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:
  • Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) [ Time Frame: post drug (6 weeks oral eszopiclone) ]
    Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).


Enrollment: 12
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
Other Name: Lunesta

Detailed Description:
see above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00889200     History of Changes
Other Study ID Numbers: 0608-002
First Submitted: April 23, 2009
First Posted: April 28, 2009
Results First Submitted: August 21, 2013
Results First Posted: November 4, 2014
Last Update Posted: September 8, 2017
Last Verified: August 2017

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