drugset / Trial / NCT00645944

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

NCT00645944 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2008-04
Primary completion
2011-04
Completion
2011-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Eszopiclone Group vs Placebo Group; p = 0.039; Mean Difference (Final Values) -3.8 (95% CI -7.5 to -0.2); Mixed Models Analysis NCT00645944 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Eszopiclone Small molecule 3 mg —