Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial

Abstract Background The problem of suicide has become increasingly common in individuals with major depressive disorder (MDD). Transcranial direct current stimulation (tDCS) is an effective treatment for MDD with 2 milliamperes (mA) for at least 30 min per day for 2 weeks. This study aims to investi...

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Main Authors: Yiming Chen, Dongbin Lyu, Fan Wang, Qinte Huang, Weichieh Yang, Mengke Zhang, Zheyi Wei, Shuxiang Shi, Shuqi Kong, Shentse Chen, Shuang He, Vivien Yang, Yiru Fang, Abdel Douiri, Wu Hong
Format: Article
Language:English
Published: BMC 2024-01-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07858-0
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author Yiming Chen
Dongbin Lyu
Fan Wang
Qinte Huang
Weichieh Yang
Mengke Zhang
Zheyi Wei
Shuxiang Shi
Shuqi Kong
Shentse Chen
Shuang He
Vivien Yang
Yiru Fang
Abdel Douiri
Wu Hong
author_facet Yiming Chen
Dongbin Lyu
Fan Wang
Qinte Huang
Weichieh Yang
Mengke Zhang
Zheyi Wei
Shuxiang Shi
Shuqi Kong
Shentse Chen
Shuang He
Vivien Yang
Yiru Fang
Abdel Douiri
Wu Hong
author_sort Yiming Chen
collection DOAJ
description Abstract Background The problem of suicide has become increasingly common in individuals with major depressive disorder (MDD). Transcranial direct current stimulation (tDCS) is an effective treatment for MDD with 2 milliamperes (mA) for at least 30 min per day for 2 weeks. This study aims to investigate the efficacy of daily duration-doubled tDCS as an adjunctive intervention for rapidly reducing suicidal ideation and improving depression in MDD patients. Methods In this double-blind, randomized, sham-controlled study, 76 MDD patients with suicidal ideation are randomly assigned to either active (n=38) or sham (n=38) tDCS group. The anode and cathode are placed over the scalp areas corresponding to left and right dorsolateral prefrontal cortex (DLPFC), respectively, and each stimulation lasts for 60 min. The primary outcome is defined as change of Beck Scale for Suicide Ideation (BSI) after 5 and 10 sessions. The change of other clinical assessments, blood biomarkers related to suicidal ideation and depressive sumptoms are defined as secondary outcomes. Blood biomarkers related to suicidal ideation are collected at baseline and after 10 sessions. Discussion This study suggests the adjunctive duration-doubled tDCS might be a novel method to rapidly reduce suicidal ideation and improve depressive symptom. The variation of biomarkers could be potential predictive models of suicide risk. Trial registration The trial protocol is registered with ClinicalTrials.gov under protocol registration number NCT05555927. Registered on September 25, 2022.
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spelling doaj.art-5c95960a637b4fd0a20b0ba526a1be712024-01-07T12:43:35ZengBMCTrials1745-62152024-01-0125111210.1186/s13063-023-07858-0Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trialYiming Chen0Dongbin Lyu1Fan Wang2Qinte Huang3Weichieh Yang4Mengke Zhang5Zheyi Wei6Shuxiang Shi7Shuqi Kong8Shentse Chen9Shuang He10Vivien Yang11Yiru Fang12Abdel Douiri13Wu Hong14Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineFuzhou Neuro-Psychiatric HospitalShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineDepartment of Psychiatry & Affective Disorders Center, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineKing’s College London, School of Life Course & Population SciencesShanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineAbstract Background The problem of suicide has become increasingly common in individuals with major depressive disorder (MDD). Transcranial direct current stimulation (tDCS) is an effective treatment for MDD with 2 milliamperes (mA) for at least 30 min per day for 2 weeks. This study aims to investigate the efficacy of daily duration-doubled tDCS as an adjunctive intervention for rapidly reducing suicidal ideation and improving depression in MDD patients. Methods In this double-blind, randomized, sham-controlled study, 76 MDD patients with suicidal ideation are randomly assigned to either active (n=38) or sham (n=38) tDCS group. The anode and cathode are placed over the scalp areas corresponding to left and right dorsolateral prefrontal cortex (DLPFC), respectively, and each stimulation lasts for 60 min. The primary outcome is defined as change of Beck Scale for Suicide Ideation (BSI) after 5 and 10 sessions. The change of other clinical assessments, blood biomarkers related to suicidal ideation and depressive sumptoms are defined as secondary outcomes. Blood biomarkers related to suicidal ideation are collected at baseline and after 10 sessions. Discussion This study suggests the adjunctive duration-doubled tDCS might be a novel method to rapidly reduce suicidal ideation and improve depressive symptom. The variation of biomarkers could be potential predictive models of suicide risk. Trial registration The trial protocol is registered with ClinicalTrials.gov under protocol registration number NCT05555927. Registered on September 25, 2022.https://doi.org/10.1186/s13063-023-07858-0Transcranial direct current stimulation (tDCS)Major depressive disorder (MDD)Suicidal ideationRandomized controlled trial (RCT)
spellingShingle Yiming Chen
Dongbin Lyu
Fan Wang
Qinte Huang
Weichieh Yang
Mengke Zhang
Zheyi Wei
Shuxiang Shi
Shuqi Kong
Shentse Chen
Shuang He
Vivien Yang
Yiru Fang
Abdel Douiri
Wu Hong
Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
Trials
Transcranial direct current stimulation (tDCS)
Major depressive disorder (MDD)
Suicidal ideation
Randomized controlled trial (RCT)
title Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
title_full Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
title_fullStr Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
title_full_unstemmed Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
title_short Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial
title_sort adjunctive duration doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation study protocol for a double blind randomized sham controlled trial
topic Transcranial direct current stimulation (tDCS)
Major depressive disorder (MDD)
Suicidal ideation
Randomized controlled trial (RCT)
url https://doi.org/10.1186/s13063-023-07858-0
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