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临床试验/NCT00621998
NCT00621998已完成4 期

A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2000年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Total scores of AIMS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Experimental

Flexible dose of olanzapine

干预措施: olanzapine (Drug)

2

Active Comparator

Flexible dose of risperidone

干预措施: risperidone (Drug)

结局指标

主要结局

Total scores of AIMS

时间窗: The change from baseline to study endpoint

次要结局

  • Total scores of BPRS(The change from baseline to study endpoint)
  • Extrapyramidal syndrome rating scale(The change from baseline to study endpoint)

研究者

发起方
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
申办方类型
Other Gov

研究点 (1)

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