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临床试验/NCT02137616
NCT02137616Unknown不适用

Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study

Central South University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Changes of PANSS total scores from baseline to 18 months

研究概览

简要总结

This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.

详细描述

The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • were help-seeking young individuals in outpatients service
  • aged 16-30 years
  • fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder

排除标准

  • a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
  • symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use;
  • neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria;
  • history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy;
  • diagnosed as having a serious and unstable medical condition.

研究组 & 干预措施

risperidone

Active Comparator

low dosage of antipsychotic drug

干预措施: risperidone (Drug)

olanzapine

Active Comparator

low doseage of antipsychotic

干预措施: olanzapine (Drug)

quetiapine

Active Comparator

low doseage of antipsychotic

干预措施: Quetiapine (Drug)

aripiprazole

Active Comparator

low doseage of antipsychotic

干预措施: Aripiprazole (Drug)

结局指标

主要结局

Changes of PANSS total scores from baseline to 18 months

时间窗: 18 months

次要结局

  • Social function(18 months)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability(18 months)

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

xiaofeng Guo

prof.

Central South University

研究点 (1)

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