- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645944
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
June 22, 2015 updated by: Cenk Tek, Yale University
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks.
A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eszopiclone Group
Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
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Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Other Names:
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Placebo Comparator: Placebo Group
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.
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Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insomnia Severity Index From Baseline.
Time Frame: 8 Weeks
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The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning).
It has adequate internal consistency (Cronbach's alpha=0.91)
and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies.
The ISI scale range is: minimum = 0, maximum = 28.
The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.
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8 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
March 25, 2008
First Submitted That Met QC Criteria
March 27, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
July 16, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Hypnotics and Sedatives
- Eszopiclone
Other Study ID Numbers
- 0702002331
- ESRC131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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