Overview

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

Status:
Terminated

Trial end date:
2009-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bristol-Myers Squibb

Collaborator:

Otsuka America Pharmaceutical

Treatments:

Antipsychotic Agents
Aripiprazole
Olanzapine
Quetiapine Fumarate
Risperidone

Criteria

Inclusion Criteria:

Patients:

- with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at
least 3 months

- with diagnosis of metabolic syndrome

- not treated for 1 of the parameters of metabolic syndrome