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BMC Psychiatry
Published in: BMC Psychiatry 1/2019

Open Access 01-12-2019 | Magnetic Resonance Imaging | Study protocol

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

Authors: Han Rong, Shu-xian Xu, Jing Zeng, Ying-jia Yang, Jie Zhao, Wen-tao Lai, Li-chang Chen, Wen-feng Deng, Xiangyang Zhang, Ying-li Zhang, Min-zhi Li, Li Xiao, Xin-hui Xie

Published in: BMC Psychiatry | Issue 1/2019

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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).
Appendix
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Metadata
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
Authors
Han Rong
Shu-xian Xu
Jing Zeng
Ying-jia Yang
Jie Zhao
Wen-tao Lai
Li-chang Chen
Wen-feng Deng
Xiangyang Zhang
Ying-li Zhang
Min-zhi Li
Li Xiao
Xin-hui Xie
Publication date
01-12-2019

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