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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645944
First Posted: March 28, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sunovion
Information provided by (Responsible Party):
Cenk Tek, Yale University
  Purpose
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.

Condition Intervention
Insomnia Schizophrenia Schizoaffective Disorder Sleep Disorders Drug: Eszopiclone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Cenk Tek, Yale University:

Primary Outcome Measures:
  • Change in Insomnia Severity Index From Baseline. [ Time Frame: 8 Weeks ]
    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'.


Enrollment: 39
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Eszopiclone
Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Other Name: Lunesta
Placebo Comparator: 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.
Drug: Placebo
Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645944


Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Sunovion
Investigators
Principal Investigator: Cenk Tek, M.D. Yale University
  More Information

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00645944     History of Changes
Other Study ID Numbers: 0702002331
ESRC131
First Submitted: March 25, 2008
First Posted: March 28, 2008
Results First Submitted: May 5, 2015
Results First Posted: July 16, 2015
Last Update Posted: October 12, 2017
Last Verified: June 2015

Additional relevant MeSH terms:
Disease
Schizophrenia
Sleep Initiation and Maintenance Disorders
Psychotic Disorders
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs