Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders
Intervention: Eszopiclone (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Cenk Tek, M.D., Principal Investigator, Affiliation: Yale University
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 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.
Clinical Details
Official title: Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Insomnia Severity Index From Baseline.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
Locations and Contacts
Connecticut Mental Health Center, New Haven, Connecticut 06519, United States
Additional Information
Starting date: April 2008
Last updated: June 22, 2015
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