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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![]() | |
First Author | Rong, Han |
Correspondent Email | xxh.med@gmail.com ; xin-hui.xie@live.com |
Contribution Rank | 6 |
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). |
Keyword | Study protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression |
2019-11-06 | |
Language | 英语 |
DOI | 10.1186/s12888-019-2320-3 |
Source Publication | BMC PSYCHIATRY
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Volume | 19Issue:1Pages:9 |
Subtype | article |
Indexed By | SCI |
Funding Project | 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] |
Publisher | BMC |
WOS Keyword | MAJOR DEPRESSION ; DISORDER ; ANXIETY ; MEMORY ; ELECTROTHERAPY ; SCHIZOPHRENIA ; CHINA ; SCALE ; P300 |
WOS Research Area | Psychiatry |
WOS Subject | Psychiatry |
WOS ID | WOS:000495586100004 |
Citation statistics | |
Document Type | 期刊论文 |
Identifier | http://ir.psych.ac.cn/handle/311026/30763 |
Collection | 中国科学院心理健康重点实验室 |
Corresponding Author | Xie, Xin-hui |
Affiliation | 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 |
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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Study protocol for a(942KB) | 期刊论文 | 出版稿 | 限制开放 | CC BY-NC-SA | Application Full Text |
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