Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

This study is currently recruiting participants.

Verified by Yale University, October 2009

First Received: March 25, 2008 Last Updated: October 5, 2009 History of Changes

Sponsor:	Yale University
Collaborator:	Sepracor, Inc.
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00645944

Purpose

The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

Condition	Intervention
Insomnia Schizophrenia Schizoaffective Disorder Sleep Disorders	Drug: Eszopiclone Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Sleep Disorders

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Change in Insomnia Severity Index from baseline. [ Time Frame: Weekly Assessment ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Drug: Eszopiclone Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
2: Placebo Comparator Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.	Drug: Placebo Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be between the ages of 18 to 64
Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
Sleep difficulties at least 2x per week in the preceding month
Be on a stable dose of antipsychotic medication
Symptomatically stable in the last 2 months
English speaking.

Exclusion Criteria:

Meet criteria for current alcohol or other substance dependence
A history of dementia, mental retardation or other neurological disorder
Not capable of giving informed consent for participation in this study.
Ongoing pregnancy
Known sensitivity to zopiclone.
Insomnia associated with medical disorders likely to impair sleep.
Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
Lack of sleep benefit from previous adequate eszopiclone treatment
History of clinically significant hepatic impairment.
Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645944

Contacts

Contact: Laura Palmese, Psy.D.	203-974-7821	laura.palmese@yale.edu
Contact: Erin Reutenauer, B.A.	203-974-7317	erin.reutenauer@yale.edu

Locations

United States, Connecticut
Connecticut Mental Health Center	Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Cenk Tek, M.D.

Sponsors and Collaborators

Yale University

Sepracor, Inc.

Investigators

Principal Investigator:

Cenk Tek, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Cenk Tek, M.D. Assistant Professor of Psychiatry )
Study ID Numbers:	0702002331, ESRC131
Study First Received:	March 25, 2008
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00645944 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Disease
Nervous System Diseases
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic
Schizophrenia

Signs and Symptoms
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010