跳至主要内容
临床试验/NCT00042224
NCT00042224已完成1 期

ECT in Clozapine Refractory Schizophrenia

Northwell Health1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2000年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Electroconvulsive therapy ECT plus clozapine for 8 weeks

干预措施: Electroconvulsive Therapy (ECT) (Procedure)

1 ECT plus clozapine

Experimental

Electroconvulsive therapy ECT plus clozapine for 8 weeks

干预措施: Clozapine (Drug)

2 Clozapine

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Petrides

Associate Professor of Psychiatry

Northwell Health

研究点 (1)

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