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

This is an open-label, long-term study of a flexible dose of a long-acting injectable formulation of risperidone (risperidone LAI) injected into the muscle at 2 week intervals for at least 12 months in patients diagnosed with schizophrenia. It is an extension of an open label study of patients with schizophrenia (RIS-USA-259) switching from treatment with an oral antipsychotic medication to long-acting injectable risperidone. Safety evaluations include incidence of adverse events, physical examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis), electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale for assessing muscle tone, gait, and abnormal movements. Efficacy assessments include measurements using the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Clinical Global Impression-Severity of Illness scale (CGI-S). Risperidone (25-50milligrams [mg]) injections, long-acting formulation, every 2 weeks for at least 1 year. Dosages may be increased (50 mgs maximum) or decreased at discretion of the investigator. Supplementary risperidone tablets (1mg) may be administered.

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