- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563017
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
July 6, 2010 updated by: Hospital Authority, Hong Kong
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wing King Lee, Dr
- Phone Number: 269 (852) 2388 8559
- Email: drwklee@gmail.com
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- Kwai Chung Hospital
-
Sub-Investigator:
- Gloria FY Chan, Dr
-
Sub-Investigator:
- Ming-ming Chan, Dr
-
Sub-Investigator:
- Vincent WH Chan, Dr
-
Sub-Investigator:
- Tin-sung Tam, Dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy/ Clinical Global Impression
Time Frame: Week 0, 4, 8,12
|
Week 0, 4, 8,12
|
Personal and Social Performance Scale
Time Frame: Week 0, 12
|
Week 0, 12
|
Extrapyramidal Symptom
Time Frame: Week 0, 4, 8,12
|
Week 0, 4, 8,12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
+Quality of life SF-36
Time Frame: Week 0,12
|
Week 0,12
|
Pain assoicated with injection VAS
Time Frame: Week 0, 4, 8, 12
|
Week 0, 4, 8, 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wing King Lee, Dr, Yaumatei Psychiatric Center, Kwai Chung Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion (Anticipated)
November 1, 2005
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 23, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
July 7, 2010
Last Update Submitted That Met QC Criteria
July 6, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Mental Disorders
- Catatonia
- Schizophrenia, Paranoid
- Schizophrenia, Disorganized
- Schizophrenia, Catatonic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- KW / EX / 04 - 038
- HARECCTR0500047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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