Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression
Rong, Han2,3; Xu, Shu-xian2,5; Zeng, Jing2; Yang, Ying-jia2; Zhao, Jie2; Lai, Wen-tao2; Chen, Li-chang6; Deng, Wen-feng7; Zhang, Xiangyang1; Zhang, Ying-li2
刊名BMC PSYCHIATRY
2019-11-06
卷号19期号:1页码:9
关键词Study protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression
DOI10.1186/s12888-019-2320-3
产权排序6
文献子类article
英文摘要

BackgroundElectroconvulsive therapy (ECT) is the most rapid and effective treatment for patients with depression, ECT can achieve remarkable antidepressant effects in the initial 3-4 sessions, but significant side effects limit its use. However, recent low-charge electrotherapy (LCE) studies have demonstrated antidepressant or antipsychotic effects with significantly fewer side effects. The aim of this study is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, to decrease side effects by using a low charge while preserving treatment efficacy.Methods/designA randomized, double-blinded, standard-controlled, parallel-group design will be carried out. We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)). We will evaluate participants across a wide variety of domains including clinical symptoms, cognitive, psychological and functional metrics. We will also perform magnetic resonance imaging (MRI) and event-related potential (ERPs) assessments during treatment to explore brain function differences between ECT and LCE.DiscussionThis research proposes a simple but completely novel ECT strategy that aims to rapidly relieve depressive symptoms and minimize side effects. The mechanism of ECT and LCE will be further discussed.Trial registrationChinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).

资助项目Sanming Project of Medicine in Shenzhen[SZSM201812052] ; Science and Technology Program of Huizhou[2018Y128] ; Science and Technology Program of Shenzhen[JCYJ20160429190927063] ; Science and Technology Program of Shenzhen[JCYJ20170413101017457] ; Chinese National Natural Science Foundation[81201047]
WOS关键词MAJOR DEPRESSION ; DISORDER ; ANXIETY ; MEMORY ; ELECTROTHERAPY ; SCHIZOPHRENIA ; CHINA ; SCALE ; P300
WOS研究方向Psychiatry
语种英语
出版者BMC
WOS记录号WOS:000495586100004
资助机构Sanming Project of Medicine in Shenzhen ; Science and Technology Program of Huizhou ; Science and Technology Program of Shenzhen ; Chinese National Natural Science Foundation
内容类型期刊论文
源URL[http://ir.psych.ac.cn/handle/311026/30762]  
专题心理研究所_中国科学院心理健康重点实验室
通讯作者Xie, Xin-hui
作者单位1.Chinese Acad Sci, Inst Psychol, CAS Key Lab Mental Hlth, Beijing, Peoples R China
2.Shenzhen Kangning Hosp, Dept Psychiat, Shenzhen, Guangdong, Peoples R China
3.Jining Med Univ, Affiliated Shenzhen Clin Coll Psychiat, Jining, Shandong, Peoples R China
4.Chinese Acad Sci, Inst Comp Technol, Key Lab Intelligent Informat Proc, Adv Comp Res Ctr, Beijing, Peoples R China
5.Second Peoples Hosp Huizhou, Ctr Acute Psychiat Serv, Huizhou, Guangdong, Peoples R China
6.Southern Med Univ, Sch Publ Hlth, Dept Biostat, Guangzhou, Guangdong, Peoples R China
7.Second Peoples Hosp Huizhou, Lab Brain Stimulat & Biol Psychiat, Brain Funct & Psychosomat Med Inst, Huizhou, Guangdong, Peoples R China
推荐引用方式
GB/T 7714
Rong, Han,Xu, Shu-xian,Zeng, Jing,et al. Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression[J]. BMC PSYCHIATRY,2019,19(1):9.
APA Rong, Han.,Xu, Shu-xian.,Zeng, Jing.,Yang, Ying-jia.,Zhao, Jie.,...&Xie, Xin-hui.(2019).Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression.BMC PSYCHIATRY,19(1),9.
MLA Rong, Han,et al."Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression".BMC PSYCHIATRY 19.1(2019):9.
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