Evidence map›Paper›PMID 31694611›Full record

ArticleBMC psychiatry2019

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.

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 and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Han RongDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Shu-Xian XuDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Jing ZengDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Ying-Jia YangDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Jie ZhaoDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Wen-Tao LaiDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Li-Chang ChenDepartment of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.
Wen-Feng DengLaboratory of Brain Stimulation and Biological Psychiatry, Brain Function and Psychosomatic Medicine Institute, Second People's Hospital of Huizhou, Huizhou, Guangdong, China.
Xiangyang ZhangCAS Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.
Ying-Li ZhangDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Min-Zhi LiDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.
Li XiaoKey Laboratory of Intelligent Information Processing, Advanced Computer Research Center, Institute of Computing Technology, Chinese Academy of Sciences, Beijing, China.
Xin-Hui XieDepartment of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China. xxh.med@gmail.com.ORCID 0000-0002-3603-3854

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 registrationChinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).

Indexed as

AdolescentAdultBrainDepressionDouble-Blind MethodElectroconvulsive TherapyEquivalence Trials as TopicEvoked PotentialsFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedNeuroimagingRandomized Controlled Trials as TopicTreatment OutcomeDepressionElectroconvulsive therapyHybrid electroconvulsive therapyRandomized controlled trialStudy protocol

Identifiers

PMID31694611
PMCPMC6836661

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.