A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Olanzapine; Risperidone

Criteria

Inclusion Criteria:

• Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder

• Taking a stable dose of olanzapine for at least 30 days

• Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months

• Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism

Exclusion Criteria:

• Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone

• A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization

• Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances

• Diagnosis of substance dependence

• Pregnant or nursing female, or those lacking adequate contraception