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

doi:10.1186/s12888-019-2320-3

	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, Han 1,2; Xu, Shu-xian 1,3; Zeng, Jing 1; Yang, Ying-jia 1; Zhao, Jie 1; Lai, Wen-tao 1; Chen, Li-chang 4; Deng, Wen-feng 5; Zhang, Xiangyang 6; Zhang, Ying-li 1; Li, Min-zhi 1; Xiao, Li 7; Xie, Xin-hui 1,3,5
	2019-11-06
发表期刊	BMC PSYCHIATRY
卷号	19 期号:1 页码:9
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).
关键词	Study protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression
DOI	10.1186/s12888-019-2320-3
收录类别	SCI
语种	英语
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] ; CAS Pioneer Hundred Talents Program[2017-074]
WOS研究方向	Psychiatry
WOS类目	Psychiatry
WOS记录号	WOS:000495586100004
出版者	BMC
引用统计	被引频次：7[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	http://119.78.100.204/handle/2XEOYT63/14892
专题	中国科学院计算技术研究所期刊论文_英文
通讯作者	Xie, Xin-hui
作者单位	1.Shenzhen Kangning Hosp, Dept Psychiat, Shenzhen, Guangdong, Peoples R China 2.Jining Med Univ, Affiliated Shenzhen Clin Coll Psychiat, Jining, Shandong, Peoples R China 3.Second Peoples Hosp Huizhou, Ctr Acute Psychiat Serv, Huizhou, Guangdong, Peoples R China 4.Southern Med Univ, Sch Publ Hlth, Dept Biostat, Guangzhou, Guangdong, Peoples R China 5.Second Peoples Hosp Huizhou, Lab Brain Stimulat & Biol Psychiat, Brain Funct & Psychosomat Med Inst, Huizhou, Guangdong, Peoples R China 6.Chinese Acad Sci, Inst Psychol, CAS Key Lab Mental Hlth, Beijing, Peoples R China 7.Chinese Acad Sci, Inst Comp Technol, Key Lab Intelligent Informat Proc, Adv Comp Res Ctr, Beijing, 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.