Eszopiclone Treatment & Cortisol Responsivity

Insomnia Clinical Trial

Official title:

Eszopiclone Treatment & Cortisol Response to HPA Axis Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889200
• Other study ID #: 0608-002
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2009
• Last updated: November 3, 2014
• Start date: May 2007
• Est. completion date: August 2009

Study information

• Verified date: November 2014
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• eszopiclone
6 weeks standard oral therapy

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)	Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).	post drug (6 weeks oral eszopiclone)	No