A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone. Efficacy will also be evaluated.

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

Details

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

Criteria

Inclusion Criteria:

• Completion of RIS-USA-256 within 7 days

Exclusion Criteria:

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

• Significant and untreated or unstable medical illness such as diabetes, hypertension, angina

• Serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system

• Pregnant or nursing females, or those lacking adequate contraception

• Known hypersensitivity or unresponsiveness to risperidone