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| Title for Public |
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
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| HAREC ID |
HARECCTR0500047
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| Scientific 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
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| 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.
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| Trial ID |
| HA REC Trial ID |
KW / EX / 04 - 038
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| Name of CREC |
KWC-CREC
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Other Trial IDs |
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| Lead Principal Investigator |
| Name |
Dr
Wing King
Lee
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| Department/Unit |
Yaumatei Psychiatric Center
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| Institute/Hospital |
Kwai Chung Hospital
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| Contact person |
| Name |
Dr
Wing King
Lee
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| Department/Unit |
Yaumatei Psychiatric Center
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| Institute/Hospital |
Kwai Chung Hospital
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| Phone |
23888559 ext 269
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| Fax |
23845697
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Internet Mail |
drwklee@gmail.com
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| Disease/s or Condition/s |
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Catatonic Schizophrenia
Disorganized Schizophrenia
Paranoid Schizophrenia
Undifferentiated Schizophrenia
Schizo-affective disorders
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| Intervention/s |
| Intervention 1 |
| Intervention Name |
Long-acting Risperidone microspheres injection
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| Type of Intervention |
Drug
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| Duration |
12 Weeks
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| Other details |
switching from oral conventional anti-psychotic drug
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| Active Control |
NO
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| Intervention 2 |
| Intervention Name |
Long-acting Risperidone microspheres injection
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| Type of Intervention |
Drug
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| Duration |
12 Weeks
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| Other details |
switching from conventional depot injection
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| Active Control |
NO
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| Intervention 3 |
| Intervention Name |
Long-acting Risperidone microspheres injection
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| Type of Intervention |
Drug
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| Duration |
12 Weeks
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| Other details |
switching from oral atypical anti-psychotic, other than oral risperdal tablet
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| Active Control |
NO
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| Inclusion and Exclusion Criteria |
| Gender |
Non-specific
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| Age |
> or equal 18 years old
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| Inclusion and Exclusion Criteria |
INCLUSION
1. Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
2. Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
3. Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
4. Subject and/or patient's relative, guardian or legal representative has signed the informed consent form
EXCLUSION
1. First antipsychotic treatment ever
2. On clozapine during the last 3 month
3. Serious unstable medical condition
4. History or current symptoms of tardive dyskinesia
5. History of neuroleptic malignant syndrome
6. Pregnant or breast-feeding female
7. Female patient of childbearing potential without adequate contraception.
8. Participation in an investigational drug trial in the 30 days prior to selection
9. Known intolerance/non-responder to risperidone
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| Study Type |
Interventional |
| Purpose |
Treatment
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| Allocation |
Nonrandomized trial
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| Masking |
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| Control |
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| Assignment |
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| Endpoint |
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| Primary Outcome/s |
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| Outcome name |
Efficacy/ Clinical Global Impression
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| Timepoint |
Week 0, 4, 8,12
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| Outcome name |
Personal and Social Performance Scale
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| Timepoint |
Week 0, 12
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| Outcome name |
Extrapyramidal Symptom
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| Timepoint |
Week 0, 4, 8,12
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| Secondary Outcome/s |
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| Outcome name |
+Quality of life SF-36
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| Timepoint |
Week 0,12
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| Outcome name |
Pain assoicated with injection VAS
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| Timepoint |
Week 0, 4, 8, 12
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| Date of First Enrollment |
2004-10-30
(yyyy-mm-dd) |
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| Target Sample Size |
30
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| Recruitment Status |
Recruiting
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| Funding Source/s |
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| Name |
Janssen Pharmaceutica
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| Address or contact information |
13/F Tower 1, Grand Century Place, Mongkok, Hong Kong
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| Primary Sponsor |
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| Name |
Janssen Pharmaceutica
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| Address or contact information |
13/F Tower 1, Grand Century Place, Mongkok, Hong Kong
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| Secondary Sponsor |
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| Research Ethics Board/Committee Approval |
YES
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| Co-Investigator/s |
| Name |
Dr Fong-yeung, Gloria Chan
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Department |
Psychiatry
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Organization |
Kwai Chung Hospital
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| Name |
Dr Ming-ming Chan
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Department |
Psychiatry
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Organization |
Kwai Chung Hospital
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| Name |
Dr Wai-hang, Vincent Chan
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Department |
Psychiatry
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Organization |
Kwai Chung Hospital
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| Name |
Dr Tin-sung Tam
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Department |
Psychiatry
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Organization |
Kwai Chung Hospital
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| Study Site/s |
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| Local site/s |
Department |
Organization |
| 1 |
Yaumatei Psychiatry Centre
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Kwai Chung Hospital
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| 2 |
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Kwai Chung Hospital
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| Clinical Specialty |
Psychiatry
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| Date of Last Follow-up |
2005-11-01
(yyyy-mm-dd) |
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| Registration Date |
2005-09-21
(yyyy-mm-dd)
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| Submission Date |
2005-09-21
(yyyy-mm-dd)
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| Record Status |
Confirmed by the Principal Investigator. January 2006
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