Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Reduction in total PANSS score and adverse events
研究概览
简要总结
The purpose of the study is to determine whether addition of electroconvulsive therapy to antipsychotic treatment improves the mental health of patients with treatment-resistant schizophrenia.
详细描述
The purpose of the study is not achieved.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
- •PANSS total score >= 70
- •CGI-S >= 4 (Clinical Global Impression)
- •PANSS score >= 4 on minimum 2 og the following items: Delusions, Conceptual disorganization,Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness, Hostility, Disorientation.
- •Previous/current treated with clozapine or refused clozapine treatment
- •Lack of response to at least three different antipsychotics
- •New antipsychotic medication prescribed more than 8 weeks before inclusion
- •Fixed dosage of antipsychotics 1 month before inclusion
- •No chance of additional neurotropic 4 weeks before inclusion
- •Signed informed consent and power of attorney
排除标准
- •Significant substance abuse
- •Somatic disease that increases the risk of complications of ECT/anesthesia
- •For women: Pregnancy or breast-feeding
- •Homelessness
- •Use of benzodiazepines (apart from tbl. oxazepam 10 mg., max 30 mg. daily)
- •Use of antiepileptic
- •Previous no effect on psychotic symptoms after ECT treatment (minimum 15 ECT- treatments)
- •Concrete suicidal plans
研究组 & 干预措施
ECT
Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
干预措施: ECT (Procedure)
ECT
Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
干预措施: Anesthesia (Drug)
SHAM ECT
Anesthesia and concomitant muscular paralysis
干预措施: SHAM ECT (Procedure)
SHAM ECT
Anesthesia and concomitant muscular paralysis
干预措施: Anesthesia (Drug)
结局指标
主要结局
Reduction in total PANSS score and adverse events
时间窗: The primary outcome will be assessed at screening, baseline and after every second week up to 72 weeks depending on the process for the individaul participant.
PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale
次要结局
未报告次要终点