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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645944
• Other study ID #: 0702002331
• Secondary ID: ESRC131
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: June 22, 2015
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Insomnia
• Parasomnias
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Eszopiclone
Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
• Placebo
Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.	8 Weeks