A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia

• Status: Completed
• Trial end date: 2000-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to show that treatment with an injectable formulation of risperidone is not less effective than and has a similar safety profile to risperidone tablets in patients with chronic schizophrenia.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria

• total score on the PANSS at study entry of >=50

• before trial entry, results of clinical hematology, biochemistry, and urinalysis tests performed at screening visit are within normal ranges

• women of child-bearing age must use adequate birth control methods, have a negative pregnancy test before the start of risperidone treatment, and not be breast feeding

• patients' schizophrenia symptoms are stable for the last 4 weeks of the run-in period.

Exclusion Criteria:

• Patients with a DSM-IV Axis I diagnosis other than schizophrenia

• documented disease of the central nervous system that can interfere with the trial assessments, for example stroke, tumor, Parkinson's Disease, Alzheimer's Disease

• moderate or severe symptoms at screening of tardive dyskinesia, a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs

• history of neuroleptic malignant syndrome, a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state

• acute, unstable or other significant and untreated medical conditions, such as infections, unstable diabetes, or unstable hypertension.