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临床试验/NCT01016145
NCT01016145Unknown4 期

Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
126
试验地点
1
主要终点
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics

研究概览

简要总结

The objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI, genetics and neuropsychological profile. Two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Schizophrenia or schizoaffective disorder
  • Age: 18-45 years olde
  • Less than 10 years of diagnosis
  • Acute exacerbation of psychotic symptoms

排除标准

  • Use of clozapine
  • Clinical unstable disease
  • Delirium and cognitive disorders

研究组 & 干预措施

First generation antipsychotic

Active Comparator

Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.

干预措施: Antipsychotics (Drug)

Second generation antipsychotics

Experimental

Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone

干预措施: Antipsychotics (Drug)

结局指标

主要结局

% responders to first generation antipsychotics vs. % responders to second generation antipsychotics

时间窗: 8-12 weeks

次要结局

  • % of treatment abandon and respective causes(8-12 weeks)

研究者

申办方类型
Other

研究点 (1)

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