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

NCT ID: NCT00645944

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-04-30

Brief 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.

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.

Conditions

Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Eszopiclone Group

Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Interventions

Eszopiclone

Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Intervention Type: DRUG

Placebo

Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Intervention Type: DRUG

Other Intervention Names

Lunesta

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Cenk Tek

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cenk Tek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

ESRC131

Identifier Type: -

Identifier Source: secondary_id

0702002331

Identifier Type: -

Identifier Source: org_study_id