Eszopiclone Treatment & Cortisol Responsivity

Completed · Phase 4

Conditions studied: Insomnia

In brief

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.

Key facts

Study ID

NCT00889200

Run by

Butler Hospital

People needed

12

Starts

2007-05-01

Expected to finish

2009-08-01

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mild to Moderate Insomnia

You may not qualify if…

• 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.

Where it is running

• Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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