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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia, Schizophrenia, Schizoaffective Disorder, Sleep Disorders

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eszopiclone Group<br>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<br>* Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.<br>* Other names: Lunesta;|
| Placebo Comparator: Placebo Group<br>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<br>* Placebo or inactive substance (sugar pill)taken each night for all weeks of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index From Baseline. | 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'. | 8 Weeks |