Eszopiclone Treatment & Cortisol Responsivity

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Butler Hospital
• Collaborator: Sunovion
• Treatments: Eszopiclone; Hydrocortisone

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.