Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
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
- 是
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
risperidone and intensive psychosocial intervention
干预措施: risperidone (Drug)
risperidone, basic
risperidone and basic psychosocial support
干预措施: risperidone (Drug)
olanzapine, intensive
olanzapine and intensive psychosocial intervention
干预措施: olanzapine (Drug)
olanzapine, basic
olanzapine and basic psychosocial support
干预措施: olanzapine (Drug)
aripiprazole, intensive
aripiprazole and intensive psychosocial intervention
干预措施: Aripiprazole (Drug)
aripiprazole, basiv
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)
