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

Schizophrenia Clinical Trial

Official title: Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder - an Open-label Follow-up Trial of RIS-INT-62 and RIS-INT-85.

Status Completed

Clinical Trial 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.

Clinical Trial Description

Noncompliance in taking medication is very common among people with schizophrenia, and is a frequent cause of relapse of symptoms. A long-acting injectable formulation that ensures slow but steady release of risperidone over a period of several weeks would eliminate the need to take medication on a daily basis, and improve compliance. This is an open-label, international, multicenter study in subjects with schizophrenia or schizoaffective disorder who completed the risperidone microspheres arm of study RIS-INT-62, or who completed study RIS-INT-85, or who dropped out of the risperidone microspheres arm of study RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone. Patients have to begin this study within 7 days of the final visit in the RIS-INT-62 or RIS-INT-85 studies. The end point visit of the RIS-INT-62 or RIS-INT-85 study serves as the first visit of this open-label study. Patients can start this study on the same dose as the last risperidone microsphere injection that they received in the previous study, or at a dose that was 12.5 mg lower or higher than the previously received dose. Patients who received 75 mg risperidone microsphere injection during study RIS-INT-62 can continue on this dose but an attempt will be made to decrease the dose to 50 mg within 3 months. The total study duration is planned to be at least 1 year or until approval of long-acting injectable risperidone in the respective country. The study hypothesis is that treatment with the long-acting injectable formulation of risperidone every 2 weeks for at least 1 year will be safe and well tolerated, as assessed by adverse event reporting, the extrapyramidal symptom rating scale, laboratory tests, vital signs measurements, physical examinations, body weight measurements, electrocardiograms, and injection site evaluations. Patients will receive injections of risperidone depot microspheres (25, 37.5, 50, or 75 mg) in their gluteal muscle at 2-weekly intervals for at least 1 year. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

• NCT number: NCT00495118
• Study type: Interventional
• Source: Janssen, LP
• Status: Completed
• Phase: Phase 3
• Start date: October 2001
• Completion date: March 2005