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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia; Metabolic Syndrome

Treatments: Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine); Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508157

Eudract Number: 2007 001217 42

CN138-489

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Aripiprazole

B

Active Comparator group

Treatment:

Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)