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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

Page last updated: August 23, 2015

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