A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to document the long-term safety of 25, 50 or 75 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to patients 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-57 or RIS-INT-61) or schizoaffective disorder (patients from RIS-INT-57 only) according to the DSM-IV criteria

• patient completed RIS-INT-57 or RIS-INT-61 or dropped out after completion of 3 injection cycles in RIS-INT-61 (i.e., at or after Visit 4)

• Patient was otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

• No DSM-IV diagnosis of substance abuse or dependence within 3 months prior to entry in RIS-INT-57 or RIS-INT-61 (excluding nicotine and caffeine dependence)

• No pregnant or breast-feeding women

• No female patient of childbearing potential without adequate contraception

• No history of severe drug allergy or hypersensitivity

• No patients known to be unresponsive to risperidone.