Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Information source: Yale University
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Cenk Tek, M.D., Principal Investigator, Affiliation: Yale University
Overall contact:
Laura Palmese, Psy.D., Phone: 203-974-7821, Email: laura.palmese@yale.edu
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: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in Insomnia Severity Index from baseline.
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
Laura Palmese, Psy.D., Phone: 203-974-7821, Email: laura.palmese@yale.edu
Connecticut Mental Health Center, New Haven, Connecticut 06519, United States; Recruiting
Cenk Tek, M.D., Principal Investigator
Additional Information
Starting date: April 2008
Ending date: April 2011
Last updated: October 5, 2009
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