Status:
COMPLETED
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Lead Sponsor:
Yale University
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 hyp...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00645944
Start Date
April 1 2008
End Date
April 1 2011
Last Update
July 16 2015
Active Locations (1)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519