A Randomized Controlled Trial study of Risperidone and Olanzapine for the Schizophrenic Patients with Neuroleptic-induced Acute Dystonia or Parkinsonism
Date Issued
2006
Date
2006
Author(s)
Chan, Hung-Yu
DOI
zh-TW
Abstract
Background: First genergation 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. There was no such shifting study in Chinese populations. We wish to establish local data to help clinical decision in such patients by a well designed randomized controlled trial. We used risperidone and olanzapine in schizophrenic patients with acute dystonia or parkinsonism side effects and copmared the incidence of needing concomitat anticholinergic drugs. We also collected the average dose in different assessment periods of risperidone and olanzapine to establish the dosing strategy guidelines for EPS intolerant schizophrenic patients.
Materials and Methods: We collected patients at Taoyuan Mental Hospital since July 2000 to May 2003. The target populations of this study were patients met the schizophrenia criteria of DSM-IV. Patients also needed to meet the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity of global impression of dystonia or parkinsonism of extrapyramidal syndrome rating scale（ESRS）. The inclusion criteria were（1）Female patients need to use reliable methods to prevent preganacy（2）Age between 18-65 y/o（3）Patients or legal responsible person agree to attend study and sign inform consent. The exclusion criteria were（1）Have other axis I diagnosis of DSM-IV（2）Have major systemic disease and influence to assessment or the use of study medications（3）Have neurological disease and influence to assessment of EPS（4）Have substance abuse or dependence in recent 1 year except tobacco or coffee. The total numbers of pateints were 70 and random assignment to risperidone or olanzapine. This study ended at July 2003 due to the study period was 8 weeks. This is a flexible dose, rater-blinded, randomized, controlled trial. The average dose of risperidone and olanzapine from baseline to study end point were 1.8 to 3.5 mg/d and 7.7 to 11.7 mg/d respectively. The primary outcome was to compare the incidence of concomitant anticholinergics to manage acute dystonia or parkinsonism in these 2 groups. The secondary outcomes were to comapre the results of rating scales in these 2 groups. The severity of EPS was assessed by ESRS. The severity of psychotic symptoms was assessed by BPRS (brief psychiatric rating scale) and CGI-S (clinical global impression-severity). The statistical methods included Chi-square or Fisher’s exact test for binominal data, Kaplan-Meier method or Cox regression for survival data, independent or paired t-test for continous variables, mixed model for repeated measures.
Results: Risperidone had significant higher incidence to use anticholinergics to manage acute dystonia or parkinsonism（OR=5.17, 95%CI=1.49-17.88, p=0.013）. Risperidone also had significant higher incidence to use anticholinergics to manage acute dystonia or parkinsonism if consider time and censor cases（log-rank test: p=0.0023; hazard ratio: 4.60, 95% CI: 1.70-11.52）. There was no significant difference in change of psychotic symptoms.
Conclusion: The results of our study favor olanzapine as better choice for schizophrenic patients with acute dystonia or parkinsonism side effects. This result was compatible with the suggestion of Maudsley prescription guideline of United Kingdom as some second generation antipsychotics as priority choice for EPS sensitive populations.
Subjects
抗精神病藥物
精神分裂症
錐體外路徑副作用
antipsychotic
schizophrenia
extrapyramidal side effects
SDGs
Type
thesis
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