ECT in Clozapine Refractory Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
研究概览
简要总结
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
详细描述
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
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
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
干预措施: Electroconvulsive Therapy (ECT) (Procedure)
1 ECT plus clozapine
Electroconvulsive therapy ECT plus clozapine for 8 weeks
干预措施: Clozapine (Drug)
2 Clozapine
Clozapine for 8 weeks
干预措施: Clozapine (Drug)
结局指标
主要结局
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
时间窗: 8 Weeks
Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.
次要结局
未报告次要终点
研究者
George Petrides
Associate Professor of Psychiatry
Northwell Health
