Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
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 effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.
Neuroleptic-Induced Tardive Dyskinesia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia|
- Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
- Total scores of BPRS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
- Extrapyramidal syndrome rating scale [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2000|
|Study Completion Date:||June 2004|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
Flexible dose of olanzapine
Active Comparator: 2
Flexible dose of risperidone
Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these 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 neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia.
Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (＞ or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621998
|Taoyuan Mental Hospital|
|Taoyuan, Taiwan, 33058|
|Study Chair:||Hung-Yu Chan, M.D., M.S.||Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan|