Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
| Tracking Information | |||||
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| First Received Date ICMJE | May 30, 2006 | ||||
| Last Updated Date | May 30, 2006 | ||||
| Start Date ICMJE | July 2000 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of using concomitant anticholinergic drugs | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale) | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism | ||||
| Official Title ICMJE | A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism | ||||
| Brief Summary | We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the incidence of using anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute dystonia or parkinsonism to test the hypothesis that these two medications have different EPS incidence in EPS intolerant population. |
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| Detailed Description | Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant anticholinergic drugs. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients. Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity (>4) of global impression of extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of concomitant anticholinergic drugs. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Risperidone and Olanzapine | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 70 | ||||
| Completion Date | July 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00331825 | ||||
| Other Study ID Numbers ICMJE | DOH-890010, TMH-91-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Taoyuan Mental Hospital | ||||
| Collaborators ICMJE | Department of Health | ||||
| Investigators ICMJE |
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| Information Provided By | Taoyuan Mental Hospital | ||||
| Verification Date | February 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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