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

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Psychotic Disorders; Schizophrenia; Schizophrenia, Catatonic; Schizophrenia, Disorganized; Schizophrenia, Paranoid

Treatments: Drug: Long-acting Risperidone microspheres injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00563017

KW / EX / 04 - 038

HARECCTR0500047

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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