Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
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.
|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|
- Change in Insomnia Severity Index from baseline. [ Time Frame: Weekly Assessment ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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: 2
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
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Cenk Tek, M.D.||Yale University|