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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00621998 |
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Date of registration:
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13/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
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Scientific title:
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A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia |
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Date of first enrolment:
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July 2000 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00621998 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Hung-Yu Chan, M.D., M.S. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age of 18-70 y/o
- Female patients did not have pregnancy plans and must agree to use reliable pregnancy
prevention methods if during childbearing age
- Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
- Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity
of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global
impression of Extrapyramidal System Rating Scale (item 42 of ESRS)
- Patients or legal responsible people agree to join study and sign informed consent
Exclusion Criteria:
- Had other axis I diagnosis of DSM-IV
- Unstable major systemic diseases
- Had neurological disorder influenced to EPS assessment
- Substance abuse or dependence other then coffee or tobacco within 6 months before
study
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuroleptic-Induced Tardive Dyskinesia
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Intervention(s)
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Drug: risperidone
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Drug: olanzapine
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Primary Outcome(s)
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Total scores of AIMS
[Time Frame: The change from baseline to study endpoint]
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Secondary Outcome(s)
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Total scores of BPRS
[Time Frame: The change from baseline to study endpoint]
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Extrapyramidal syndrome rating scale
[Time Frame: The change from baseline to study endpoint]
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Secondary ID(s)
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DOH-890010
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TMH-91-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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