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

Background Electroconvulsive 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 d...
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Autor*in:	Rong, Han [verfasserIn] Xu, Shu-xian Zeng, Jing Yang, Ying-jia Zhao, Jie Lai, Wen-tao Chen, Li-chang Deng, Wen-feng Zhang, Xiangyang Zhang, Ying-li Li, Min-zhi Xiao, Li Xie, Xin-hui

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Study protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression

Anmerkung:	© The Author(s). 2019

Übergeordnetes Werk:	Enthalten in: BMC psychiatry - London : BioMed Central, 2001, 19(2019), 1 vom: 06. Nov.
Übergeordnetes Werk:	volume:19 ; year:2019 ; number:1 ; day:06 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s12888-019-2320-3

Katalog-ID:	SPR027819787

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520			\|a Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).
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allfields	10.1186/s12888-019-2320-3 doi (DE-627)SPR027819787 (SPR)s12888-019-2320-3-e DE-627 ger DE-627 rakwb eng Rong, Han verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Xu, Shu-xian aut Zeng, Jing aut Yang, Ying-jia aut Zhao, Jie aut Lai, Wen-tao aut Chen, Li-chang aut Deng, Wen-feng aut Zhang, Xiangyang aut Zhang, Ying-li aut Li, Min-zhi aut Xiao, Li aut Xie, Xin-hui (orcid)0000-0002-3603-3854 aut Enthalten in BMC psychiatry London : BioMed Central, 2001 19(2019), 1 vom: 06. Nov. (DE-627)331018799 (DE-600)2050438-X 1471-244X nnns volume:19 year:2019 number:1 day:06 month:11 https://dx.doi.org/10.1186/s12888-019-2320-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 06 11
spelling	10.1186/s12888-019-2320-3 doi (DE-627)SPR027819787 (SPR)s12888-019-2320-3-e DE-627 ger DE-627 rakwb eng Rong, Han verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Xu, Shu-xian aut Zeng, Jing aut Yang, Ying-jia aut Zhao, Jie aut Lai, Wen-tao aut Chen, Li-chang aut Deng, Wen-feng aut Zhang, Xiangyang aut Zhang, Ying-li aut Li, Min-zhi aut Xiao, Li aut Xie, Xin-hui (orcid)0000-0002-3603-3854 aut Enthalten in BMC psychiatry London : BioMed Central, 2001 19(2019), 1 vom: 06. Nov. (DE-627)331018799 (DE-600)2050438-X 1471-244X nnns volume:19 year:2019 number:1 day:06 month:11 https://dx.doi.org/10.1186/s12888-019-2320-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 06 11
allfields_unstemmed	10.1186/s12888-019-2320-3 doi (DE-627)SPR027819787 (SPR)s12888-019-2320-3-e DE-627 ger DE-627 rakwb eng Rong, Han verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Xu, Shu-xian aut Zeng, Jing aut Yang, Ying-jia aut Zhao, Jie aut Lai, Wen-tao aut Chen, Li-chang aut Deng, Wen-feng aut Zhang, Xiangyang aut Zhang, Ying-li aut Li, Min-zhi aut Xiao, Li aut Xie, Xin-hui (orcid)0000-0002-3603-3854 aut Enthalten in BMC psychiatry London : BioMed Central, 2001 19(2019), 1 vom: 06. Nov. (DE-627)331018799 (DE-600)2050438-X 1471-244X nnns volume:19 year:2019 number:1 day:06 month:11 https://dx.doi.org/10.1186/s12888-019-2320-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 06 11
allfieldsGer	10.1186/s12888-019-2320-3 doi (DE-627)SPR027819787 (SPR)s12888-019-2320-3-e DE-627 ger DE-627 rakwb eng Rong, Han verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Xu, Shu-xian aut Zeng, Jing aut Yang, Ying-jia aut Zhao, Jie aut Lai, Wen-tao aut Chen, Li-chang aut Deng, Wen-feng aut Zhang, Xiangyang aut Zhang, Ying-li aut Li, Min-zhi aut Xiao, Li aut Xie, Xin-hui (orcid)0000-0002-3603-3854 aut Enthalten in BMC psychiatry London : BioMed Central, 2001 19(2019), 1 vom: 06. Nov. (DE-627)331018799 (DE-600)2050438-X 1471-244X nnns volume:19 year:2019 number:1 day:06 month:11 https://dx.doi.org/10.1186/s12888-019-2320-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 06 11
allfieldsSound	10.1186/s12888-019-2320-3 doi (DE-627)SPR027819787 (SPR)s12888-019-2320-3-e DE-627 ger DE-627 rakwb eng Rong, Han verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213 Xu, Shu-xian aut Zeng, Jing aut Yang, Ying-jia aut Zhao, Jie aut Lai, Wen-tao aut Chen, Li-chang aut Deng, Wen-feng aut Zhang, Xiangyang aut Zhang, Ying-li aut Li, Min-zhi aut Xiao, Li aut Xie, Xin-hui (orcid)0000-0002-3603-3854 aut Enthalten in BMC psychiatry London : BioMed Central, 2001 19(2019), 1 vom: 06. Nov. (DE-627)331018799 (DE-600)2050438-X 1471-244X nnns volume:19 year:2019 number:1 day:06 month:11 https://dx.doi.org/10.1186/s12888-019-2320-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 06 11
language	English
source	Enthalten in BMC psychiatry 19(2019), 1 vom: 06. Nov. volume:19 year:2019 number:1 day:06 month:11
sourceStr	Enthalten in BMC psychiatry 19(2019), 1 vom: 06. Nov. volume:19 year:2019 number:1 day:06 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Study protocol Randomized controlled trial Hybrid electroconvulsive therapy Electroconvulsive therapy Depression
isfreeaccess_bool	true
container_title	BMC psychiatry
authorswithroles_txt_mv	Rong, Han @@aut@@ Xu, Shu-xian @@aut@@ Zeng, Jing @@aut@@ Yang, Ying-jia @@aut@@ Zhao, Jie @@aut@@ Lai, Wen-tao @@aut@@ Chen, Li-chang @@aut@@ Deng, Wen-feng @@aut@@ Zhang, Xiangyang @@aut@@ Zhang, Ying-li @@aut@@ Li, Min-zhi @@aut@@ Xiao, Li @@aut@@ Xie, Xin-hui @@aut@@
publishDateDaySort_date	2019-11-06T00:00:00Z
hierarchy_top_id	331018799
id	SPR027819787
language_de	englisch
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author	Rong, Han
spellingShingle	Rong, Han misc Study protocol misc Randomized controlled trial misc Hybrid electroconvulsive therapy misc Electroconvulsive therapy misc Depression 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
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topic_title	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 Study protocol (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Hybrid electroconvulsive therapy (dpeaa)DE-He213 Electroconvulsive therapy (dpeaa)DE-He213 Depression (dpeaa)DE-He213
topic	misc Study protocol misc Randomized controlled trial misc Hybrid electroconvulsive therapy misc Electroconvulsive therapy misc Depression
topic_unstemmed	misc Study protocol misc Randomized controlled trial misc Hybrid electroconvulsive therapy misc Electroconvulsive therapy misc Depression
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title	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
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title_full	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
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author_browse	Rong, Han Xu, Shu-xian Zeng, Jing Yang, Ying-jia Zhao, Jie Lai, Wen-tao Chen, Li-chang Deng, Wen-feng Zhang, Xiangyang Zhang, Ying-li Li, Min-zhi Xiao, Li Xie, Xin-hui
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title_sort	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
title_auth	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
abstract	Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). © The Author(s). 2019
abstractGer	Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). © The Author(s). 2019
abstract_unstemmed	Background Electroconvulsive 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/design A 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. Discussion This 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 registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019). © The Author(s). 2019
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title_short	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
url	https://dx.doi.org/10.1186/s12888-019-2320-3
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author2	Xu, Shu-xian Zeng, Jing Yang, Ying-jia Zhao, Jie Lai, Wen-tao Chen, Li-chang Deng, Wen-feng Zhang, Xiangyang Zhang, Ying-li Li, Min-zhi Xiao, Li Xie, Xin-hui
author2Str	Xu, Shu-xian Zeng, Jing Yang, Ying-jia Zhao, Jie Lai, Wen-tao Chen, Li-chang Deng, Wen-feng Zhang, Xiangyang Zhang, Ying-li Li, Min-zhi Xiao, Li Xie, Xin-hui
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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

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