A Study of Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone (RISPERDAL® CONSTA™)

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in need of a therapy change.

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Olanzapine; Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)

• patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit

• patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request.

Exclusion Criteria:

• Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation

• known hypersensitivity, intolerance, or unresponsiveness to risperidone

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

• tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles

• pregnant or nursing females, or those lacking adequate contraception