A Study Comparing the Efficacy of Long-acting Injectable Risperidone and Olanzapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to document both short-term, as well as long-term efficacy and safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine for the treatment of patients with schizophrenia or schizoaffective disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Olanzapine; Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)

• Positive and Negative Syndrome Scale (PANSS) total score =>50, indicating at least a minimum level of mental and behavioral disorders

• Recent hospitalization or an episode of psychosis requiring medical intervention

• Body Mass Index (BMI) <=40 (BMI >=30 indicates obesity)

Exclusion Criteria:

• Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder

• History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness

• Past treatment with clozapine

• Pregnant or nursing females, or those lacking adequate contraception

• Known sensitivity or unresponsiveness to risperidone or olanzapine

• Treatment with a long-acting injectable antipsychotic drug near the time of the trial start