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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 21, 2007

Last Updated Date

June 23, 2009

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Efficacy/ Clinical Global Impression [ Time Frame: Week 0, 4, 8,12 ]
Personal and Social Performance Scale [ Time Frame: Week 0, 12 ]
Extrapyramidal Symptom [ Time Frame: Week 0, 4, 8,12 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00563017 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

+Quality of life SF-36 [ Time Frame: Week 0,12 ]
Pain assoicated with injection VAS [ Time Frame: Week 0, 4, 8, 12 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Long-acting Risperidone microspheres injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Wing King Lee, Dr

(852) 2388 8559 ext 269

drwklee@gmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00563017

Responsible Party

Study ID Numbers ^ICMJE

KW / EX / 04 - 038, HARECCTR0500047

Study Sponsor ^ICMJE

Hospital Authority, Hong Kong

Collaborators ^ICMJE

Janssen Pharmaceutica N.V., Belgium

Investigators ^ICMJE

Principal Investigator:

Wing King Lee, Dr

Yaumatei Psychiatric Center, Kwai Chung Hospital

Information Provided By

Hospital Authority, Hong Kong

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP