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

Primary Purpose

Insomnia, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eszopiclone Group

Placebo Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2008
Last Updated
June 22, 2015
Sponsor
Yale University
Collaborators
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00645944
Brief Title
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Official Title
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Schizophrenia, Schizoaffective Disorder, Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eszopiclone Group
Arm Type
Experimental
Arm Description
Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index From Baseline.
Description
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'.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenk Tek, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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