A Long-term Safety Study for Long-acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to document the long-term safety of 25, 37.5, or 50 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to subjects with schizophrenia or schizoaffective disorder.

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

Details

• Lead Sponsor: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia (patients from RIS-INT-62 or RIS-INT-85) or schizoaffective disorder (patients from RIS-INT-62 only) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria

• patient completed the risperidone microspheres arm of RIS-INT-62, or completed RIS-INT-85, or dropped out of the risperidone microspheres arm of RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone

• informed consent signed by the patient

• patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

• A DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder

• no pregnant or breast-feeding women

• no female patient of childbearing potential without adequate contraception

• no history of severe drug allergy or hypersensitivity

• no subjects known to be unresponsive to risperidone.