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Keep this study
Lead
Yale University
With
Sumitomo Pharma America, Inc.
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.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
