NCT00236587

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

An Open Label, Long Term Trial of Risperidone Long Acting Microspheres in the Treatment of Patients Diagnosed With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	risperidone

Timeline

• Start date: 2001-11-01
• Completion: 2004-02-01
• First posted: 2005-10-12
• Last updated: 2011-06-08