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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00563017
• Other study ID #: KW / EX / 04 - 038
• Secondary ID: HARECCTR0500047
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2007
• Last updated: July 6, 2010
• Start date: October 2004
• Est. completion date: November 2005

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Wing King Lee, Dr
• Phone: (852) 2388 8559
• Email: drwklee[@]gmail.com
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Catatonic
• Schizophrenia, Disorganized
• Schizophrenia, Paranoid

Intervention

Drug:
• Long-acting Risperidone microspheres injection

Locations

Country	Name	City	State
China	Kwai Chung Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy/ Clinical Global Impression		Week 0, 4, 8,12
Primary	Personal and Social Performance Scale		Week 0, 12
Primary	Extrapyramidal Symptom		Week 0, 4, 8,12
Secondary	+Quality of life SF-36		Week 0,12
Secondary	Pain assoicated with injection VAS		Week 0, 4, 8, 12

External Links

•   HAREC Clinical Trial Registry