Eszopiclone Treatment & Cortisol Responsivity

Phase 4

Completed

• Conditions: Insomnia
• Interventions: Drug: eszopiclone

• Registration Number: NCT00889200
• Lead Sponsor: 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.

Detailed Description

see above

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-12
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Study Completion: 2009-08
• Results First Submitted: 2013-08-21
• Results First Submitted QC: 2014-11-03
• Results First Posted: 2014-11-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label Eszopiclone	eszopiclone	Standard dosing of drug for 6 weeks for insomnia

Primary Outcome Measures

Name	Time	Method
Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)	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).

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States