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OpenTrials
Completed

NCT Number: NCT00889200

Eszopiclone Treatment & Cortisol Responsivity

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eszopiclone

Drug

6 weeks standard oral therapy

Other names: Lunesta

Primary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Official study title

Eszopiclone Treatment & Cortisol Response to HPA Axis Tests

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Apr 28, 2009
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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