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

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Cenk Tek, Yale University
ClinicalTrials.gov Identifier:
NCT00645944
First received: March 25, 2008
Last updated: June 22, 2015
Last verified: June 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Yale University:

Primary Outcome Measures:
  • Change in Insomnia Severity Index From Baseline. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00645944     History of Changes
Other Study ID Numbers: 0702002331, ESRC131
Study First Received: March 25, 2008
Results First Received: May 5, 2015
Last Updated: June 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parasomnias
Psychotic Disorders
Schizophrenia
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015