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...
Date First Received: November 21, 2007
Last Updated: June 23, 2009
Verified by: Hospital Authority, Hong Kong, June 2008
Clinical Trial Phase: N/A | Start Date: October 2004
Overall Status: Recruiting
Estimated Enrollment: 30
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Long-acting Risperidone microspheres injection
Outcome Measures for this Clinical Trial
Primary Measures
- Efficacy/ Clinical Global Impression
- Time Frame: Week 0, 4, 8,12
- Time Frame: Week 0, 4, 8,12
- Personal and Social Performance Scale
- Time Frame: Week 0, 12
- Time Frame: Week 0, 12
- Extrapyramidal Symptom
- Time Frame: Week 0, 4, 8,12
- Time Frame: Week 0, 4, 8,12
Secondary Measures
- +Quality of life SF-36
- Time Frame: Week 0,12
- Time Frame: Week 0,12
- Pain assoicated with injection VAS
- Time Frame: Week 0, 4, 8, 12
- Time Frame: Week 0, 4, 8, 12
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Authority, Hong Kong
Overall Clinical Trial Officials and Contacts
Wing King Lee, Dr Principal Investigator Yaumatei Psychiatric Center, Kwai Chung Hospital
Overall Contact: Wing King Lee, Dr (852) 2388 8559 drwklee@gmail.com
Additional Information
Information obtained from ClinicalTrials.gov on March 18, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563017
Study ID Number: KW / EX / 04 - 038
ClinicalTrials.gov Identifier: NCT00563017
Health Authority: Hong Kong: Ethics Committee
Clinical Trials Authorship and Review
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