Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
试验速览
- 阶段
- 3 期
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.
详细描述
This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the DSM-5 diagnostic criteria for schizophrenia,
- •be 18-55 years of age,
- •treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
- •Informed consent.
排除标准
- •Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
- •Patients with contraindications to even one of the proposed treatment arms are excluded.
- •Patients with risks such as extreme agitation, stupor or suicide are excluded.
- •Female patients with pregnancy or breast-feeding are also excluded.
研究组 & 干预措施
Clozapine
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml
干预措施: Clozapine (Drug)
Clozapine+Amisulpride
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d
干预措施: Clozapine (Drug)
Clozapine+Gingke biloba
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d
干预措施: Clozapine (Drug)
MECT
MECT:The treatment lasted for 4 months,16 times in total
干预措施: MECT (Device)
MST
MST:The treatment lasted for 4 months,16 times in total
干预措施: MECT (Device)
DBS
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
干预措施: DBS (Device)
结局指标
主要结局
Response rate
时间窗: Change from baseline PANSS score at 12 weeks
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
次要结局
- Adverse reactions(baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks)
- Neurocognitive assessments and social function(baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Clinical assessements(baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks)