Eszopiclone Treatment & Cortisol Responsivity

This study is ongoing, but not recruiting participants.

First Received: April 23, 2009 Last Updated: April 27, 2009 History of Changes

Sponsors and Collaborators:	Butler Hospital Sepracor, Inc.
Information provided by:	Butler Hospital
ClinicalTrials.gov Identifier:	NCT00889200

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 IV

Drug Information available for: Eszopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Eszopiclone Treatment & Cortisol Response to HPA Axis Tests

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
Estimated Study Completion Date:	August 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open-label Eszopiclone: Experimental 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

Sepracor, Inc.

Investigators

Principal Investigator:

Linda Carpenter, MD

Butler Hospital

More Information

No publications provided

Responsible Party:	Butler Hospital ( Linda Carpenter )
Study ID Numbers:	0608-002
Study First Received:	April 23, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00889200 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hydrocortisone
Cortisol succinate
Hydrocortisone acetate

ClinicalTrials.gov processed this record on May 07, 2009