Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00645944|
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Schizophrenia Schizoaffective Disorder Sleep Disorders||Drug: Eszopiclone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
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.
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.
Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
- 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'.
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
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Cenk Tek, M.D.||Yale University|