Eszopiclone Treatment & Cortisol Responsivity

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. Identifier: NCT00889200
Recruitment Status : Completed
First Posted : April 28, 2009
Results First Posted : November 4, 2014
Last Update Posted : September 8, 2017
Information provided by (Responsible Party):
Butler Hospital

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 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 or disease Intervention/treatment Phase
Insomnia Drug: eszopiclone Phase 4

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Eszopiclone Treatment & Cortisol Response to HPA Axis Tests
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open-label Eszopiclone
Standard dosing of drug for 6 weeks for insomnia
Drug: eszopiclone
6 weeks standard oral therapy
Other Name: Lunesta

Primary Outcome Measures :
  1. 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).

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

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.

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 identifier (NCT number): NCT00889200

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Principal Investigator: Linda Carpenter, MD Butler Hospital

Responsible Party: Butler Hospital Identifier: NCT00889200     History of Changes
Other Study ID Numbers: 0608-002
First Posted: April 28, 2009    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: September 8, 2017
Last Verified: August 2017

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