The Optimal Treatment for Treatment-resistant Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Positive and Negative Syndrome Scale [PANSS]
研究概览
简要总结
The Optimal Treatment for Treatment-resistant Schizophrenia
详细描述
To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of schizophrenia according to DSM-V
- •18～60 years old
- •2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration;
- •Signed an informed consent
排除标准
- •patients to be diagnosed according to DSM-V for substance abused, development delayed
- •suffering from serious physical disease and can not accept the treatment
- •MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
- •allergic to risperidone ,aripiprazole, or sodium valproate
- •Participated in any clinical subject within 30 days
- •Pregnancy or lactation
研究组 & 干预措施
risperidone with clozapine
risperidone, dosage form: 1 mg, dosage and frequency:3.0~6.0 mg/d; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks
干预措施: Risperidone with Clozapine (Drug)
aripiprazole with clozapine
aripiprazole, dosage form: 5 mg, dosage and frequency:15~30 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks
干预措施: Aripiprazole with Clozapine (Drug)
sodium valproate with clozapine
sodium valproate, dosage form: 250 mg, dosage and frequency:600~1200 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 3 months.
干预措施: sodium valproate with Clozapine (Drug)
clozapine
only clozapine, dosage and frequency:300~600 mg/d;
干预措施: clozapine (Device)
Modified electroconvulsive therapy with clozapine
10 times MECT for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.
干预措施: modified electroconvulsive therapy(MECT) with Clozapine (Device)
Magnetic seizure therapy with clozapine
10 times MST for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.
干预措施: Magnetic seizure therapy(MST) with Clozapine (Device)
结局指标
主要结局
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
时间窗: At baseline, 4th week, 8th week,12th week
次要结局
- Change from baseline in clinical global impression [CGI](At baseline, 4th week, 8th week,12th week)
- Change from baseline in Abnormal Involuntary Movement Scale[AIMS](At baseline, 4th week, 8th week,12th week)
- Change from baseline in Simpson-Angus Scale [SAS](At baseline, 4th week, 8th week,12th week)