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 Kong1 site in 1 country30 target enrollmentOctober 2004

ConditionsSchizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia Psychotic Disorders

DrugsLong-acting Risperidone microspheres injection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia, Catatonic
Sponsor: Hospital Authority, Hong Kong
Enrollment: 30
Locations: 1
Primary Endpoint: Personal and Social Performance Scale
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

November 2005

Last Updated

15 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hospital Authority, Hong Kong

Eligibility 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