Eszopiclone Treatment & Cortisol Responsivity

• Sponsor: Butler Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00889200
• Collaborator: Sunovion (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: eszopiclone	Phase 4

Detailed Description

see above

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Eszopiclone Treatment & Cortisol Response to HPA Axis Tests
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open-label Eszopiclone Standard dosing of drug for 6 weeks for insomnia	Drug: eszopiclone; 6 weeks standard oral therapy; Other Names: Lunesta

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Butler Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Butler Hospital
• Sunovion

Investigators

• Principal Investigator: Linda Carpenter, MD, Butler Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Butler Hospital
• ClinicalTrials.gov Identifier: NCT00889200
• Other Study ID Numbers: 0608-002
• First Posted: Apr 28, 2009
• Last Update Posted: Sep 8, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Eszopiclone

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the community via flyers and through Internet and newspaper advertisements for "healthy adults experiencing problems with sleep." Voluntary written informed consent was obtained for the study, which was approved by the Butler Hospital Institutional Review Board.
Pre-assignment Detail	Excluded subjects met criteria for current major depressive disorder (MDD) or other major Axis I psychiatric or substance use disorders. Subjects reporting < 6 hours of sleep/night and with score > 10 on Insomnia Severity Index (ISI) qualified. General good health required on physical and neurological examinations and on laboratory studies.

Arm/Group Title	Open-label Eszopiclone
Arm/Group Description	Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Open-label Eszopiclone
Arm/Group Description	Standard dosing of drug for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	7 58.3%
Male	5 41.7%
Depressive Symptoms (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	13.83 (8.24)
plasma cortisol response to standardized dexamethasone/Corticotropin Releasing Hormone (DEX/CRH) (nmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nmol/L]	146.23 (161.85)
Insomnia Severity Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.23 (2.93)

Outcome Measures

1. Primary Outcome

Title	Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)
Description	Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).
Time Frame	post drug (6 weeks oral eszopiclone)

Outcome Measure Data

Analysis Population Description

All subjects completed all study procedures

Arm/Group Title	Open-label Eszopiclone
Arm/Group Description	After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
Measure Participants	12
Measure paired t-test cortisol reactivity	12
Mean (Standard Deviation) [nmol/L]	108.98 (129.19)

Adverse Events

Time Frame	Over 6 weeks on drug; verbal report by subject at clinic assessments every 2 weeks
Arm/Group Title	Open-label Eszopiclone
Arm/Group Description	Standard dosing of drug for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy
All Cause Mortality
	Open-label Eszopiclone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Open-label Eszopiclone
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Open-label Eszopiclone
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.