Eszopiclone Treatment & Cortisol Responsivity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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see above

Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Open-label Eszopiclone

Standard dosing of drug for 6 weeks for insomnia

Group Type EXPERIMENTAL

eszopiclone

Intervention Type DRUG

6 weeks standard oral therapy

Interventions

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eszopiclone

6 weeks standard oral therapy

Intervention Type DRUG

Other Intervention Names

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Lunesta

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No