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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, Han1,2; Xu, Shu-xian1,3; Zeng, Jing1; Yang, Ying-jia1; Zhao, Jie1; Lai, Wen-tao1; Chen, Li-chang4; Deng, Wen-feng5; Zhang, Xiangyang6; Zhang, Ying-li1; Li, Min-zhi1; Xiao, Li7; Xie, Xin-hui1,3,5
First AuthorRong, Han
Correspondent Emailxxh.med@gmail.com ; xin-hui.xie@live.com
Contribution Rank6
Abstract

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).

KeywordStudy protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression
2019-11-06
Language英语
DOI10.1186/s12888-019-2320-3
Source PublicationBMC PSYCHIATRY
Volume19Issue:1Pages:9
Subtypearticle
Indexed BySCI
Funding ProjectSanming 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]
PublisherBMC
WOS KeywordMAJOR DEPRESSION ; DISORDER ; ANXIETY ; MEMORY ; ELECTROTHERAPY ; SCHIZOPHRENIA ; CHINA ; SCALE ; P300
WOS Research AreaPsychiatry
WOS SubjectPsychiatry
WOS IDWOS:000495586100004
Citation statistics
Document Type期刊论文
Identifierhttp://ir.psych.ac.cn/handle/311026/30763
Collection中国科学院心理健康重点实验室
Corresponding AuthorXie, Xin-hui
Affiliation1.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
Recommended Citation
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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