NCT00645944

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Insomnia
• Schizophrenia
• Schizoaffective Disorder
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
DRUG	Placebo	Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-03-28
• Last updated: 2015-07-16
• Results posted: 2015-07-16

Locations

1 site across 1 country: United States