Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

• Status: Unknown status
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.

• Phase: N/A

Details

• Lead Sponsor: Hospital Authority, Hong Kong
• Collaborator: Janssen Pharmaceutica N.V., Belgium
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy

• Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic

• Subject has been symptomatically stable on a stable dose of an antipsychotic the last month

• Subject and/or patient's relative, guardian or legal representative has signed the informed consent form

Exclusion Criteria:

• First antipsychotic treatment ever

• On clozapine during the last 3 month

• Serious unstable medical condition

• History or current symptoms of tardive dyskinesia

• History of neuroleptic malignant syndrome

• Pregnant or breast-feeding female

• Female patient of childbearing potential without adequate contraception.

• Participation in an investigational drug trial in the 30 days prior to selection

• Known intolerance/non-responder to risperidone