Eszopiclone Treatment & Cortisol Responsivity

Butler Hospital

Status and phase

Completed

Phase 4

Conditions

Insomnia

Treatments

Drug: eszopiclone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00889200

0608-002

Details and patient eligibility

About

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.

Full description

see above

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.