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临床试验/NCT01057849
NCT01057849Unknown不适用

Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study

Peking University6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2008年9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
600
试验地点
6
主要终点
the time the patients remain stable

研究概览

简要总结

Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.

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
16 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • schizophrenic patients diagnosed with DSM-IV criteria by SCID-I.
  • age between 16-45 years old
  • with disease course less than 3 years and during their first episode
  • without receiving systematic antipsychotic treatment less than 1 month

排除标准

  • organic disease or unstable physical diseases.
  • brain trauma with loss of consciousness more than 1 hour
  • current substance misuse (in 3 months) or any substance dependence.
  • pregnant women.
  • patients with severe suicidal imaginations or behavior.
  • mental retardation
  • contradict to the study drugs

研究组 & 干预措施

Risperidone, Intensive

Experimental

risperidone and intensive psychosocial intervention

干预措施: risperidone (Drug)

risperidone, basic

Active Comparator

risperidone and basic psychosocial support

干预措施: risperidone (Drug)

olanzapine, intensive

Experimental

olanzapine and intensive psychosocial intervention

干预措施: olanzapine (Drug)

olanzapine, basic

Active Comparator

olanzapine and basic psychosocial support

干预措施: olanzapine (Drug)

aripiprazole, intensive

Experimental

aripiprazole and intensive psychosocial intervention

干预措施: Aripiprazole (Drug)

aripiprazole, basiv

Active Comparator

aripiprazole and basic psychosocial support

干预措施: Aripiprazole (Drug)

结局指标

主要结局

the time the patients remain stable

时间窗: 1 year

次要结局

  • Scoring of PANSS and PSP(1 year)

研究者

发起方
Peking University
申办方类型
Other

研究点 (6)

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