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

Not Applicable

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

• Registration Number: NCT00563017
• Lead Sponsor: Hospital Authority, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy/ Clinical Global Impression	Week 0, 4, 8,12
Extrapyramidal Symptom	Week 0, 4, 8,12
Personal and Social Performance Scale	Week 0, 12

Secondary Outcome Measures

Name	Time	Method
Pain assoicated with injection VAS	Week 0, 4, 8, 12
+Quality of life SF-36	Week 0,12

Trial Locations

Locations (1)

Kwai Chung Hospital; 🇨🇳 Hong Kong, China