NCT00216528

A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

Detailed description

Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia. The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	risperidone

Timeline

• Start date: 2005-07-01
• Completion: 2007-04-01
• First posted: 2005-09-22
• Last updated: 2010-04-27