Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- the time to discontinued treatment and the rate of relapse/rehospitalization
研究概览
简要总结
Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.
详细描述
The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.
We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were 16 to 50 years of age;
- •had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
- •were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale [PANSS] or a decrease of fifty percent from acute period in the total score on PANSS)
- •and taken maintenance treatment with any one of the following seven oral antipsychotics:
- •chlorpromazine
- •sulpiride clozapine
- •risperidone
- •olanzapine
- •quetiapine
- •aripiprazole
排除标准
- •Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
- •had a history of serious adverse reactions to the proposed treatment;
- •were pregnant or breastfeeding; or had a serious and unstable medical condition.
- •Patients were excluded if they were unable to provide informed consent
研究组 & 干预措施
1
the comparator arm will only receive one of the seven antipsychotic
干预措施: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole (Drug)
2
the experimental group will receive one of the seven study drugs combination with psychosocial intervention
干预措施: psychosocial intervention (Behavioral)
结局指标
主要结局
the time to discontinued treatment and the rate of relapse/rehospitalization
次要结局
- clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.