Eszopiclone Treatment & Cortisol Responsivity

NCT00889200 | Completed Phase 4 Results

• 1 other identifier: 0608-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

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

  Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).

  post drug (6 weeks oral eszopiclone)

Study Arms (1)

Open-label Eszopiclone

EXPERIMENTAL

Standard dosing of drug for 6 weeks for insomnia

Drug: eszopiclone

Interventions

eszopiclone DRUG

6 weeks standard oral therapy

Also known as: Lunesta

Open-label Eszopiclone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Butler Hospital: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Linda Carpenter, MD
• Organization: Butler Hospital

Linda_Carpenter_MD@Brown.edu

401 455 6349

Study Officials

• Linda Carpenter, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 28, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: September 8, 2017
• Results First Posted: November 4, 2014

Record last verified: 2017-08

Locations

US (1)