drugset / Trial / NCT00508157

A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

NCT00508157

RandomizedParallel-groupOpen-labelTreatment

Summary

258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

Timeline

Start
2007-11
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 5 mg Oral
Subject Aripiprazole Other / unclassified 30 mg Oral
Comparator Olanzapine Small molecule Oral
Comparator Quetiapine Small molecule Oral
Comparator Risperidone Other / unclassified Oral