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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Authority, Hong Kong
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563017
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia Psychotic Disorders |
Drug: Long-acting Risperidone microspheres injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hospital Authority, Hong Kong:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- +Quality of life SF-36 [ Time Frame: Week 0,12 ]
- Pain assoicated with injection VAS [ Time Frame: Week 0, 4, 8, 12 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | November 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563017
Contacts
| Contact: Wing King Lee, Dr | (852) 2388 8559 ext 269 | drwklee@gmail.com |
Locations
| China | |
| Kwai Chung Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: Gloria FY Chan, Dr | |
| Sub-Investigator: Ming-ming Chan, Dr | |
| Sub-Investigator: Vincent WH Chan, Dr | |
| Sub-Investigator: Tin-sung Tam, Dr | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Janssen Pharmaceutica N.V., Belgium
Investigators
| Principal Investigator: | Wing King Lee, Dr | Yaumatei Psychiatric Center, Kwai Chung Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00563017 History of Changes |
| Other Study ID Numbers: | KW / EX / 04 - 038, HARECCTR0500047 |
| Study First Received: | November 21, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Catatonic Schizophrenia Disorganized Schizophrenia Paranoid Schizophrenia Undifferentiated Schizophrenia Schizo-affective disorders |
Additional relevant MeSH terms:
|
Catatonia Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents |
Risperidone Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013