drugset / Trial / NCT02118688

Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium

NCT02118688

Phase 4 Withdrawn Rochester General Hospital
RandomizedFactorialQuadruple-blindTreatment

Summary

The purpose of this randomized clinical trial is to determine whether risperidone alone, trazodone alone, or a combination of risperidone and trazodone is superior for the treatment of ICU acquired delirium. The hypothesis is that combination therapy is superior to either agent alone in treating ICU acquired delirium and sustaining delirium free time.

Timeline

Start
2011-03
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Risperidone Other / unclassified 3 mg Oral
Comparator Trazodone Small molecule 200 mg Oral

Indications