The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorBRUNONI, Andre Russowsky
dc.contributor.authorSAMPAIO-JUNIOR, Bernardo
dc.contributor.authorMOFFA, Adriano Henrique
dc.contributor.authorBORRIONE, Lucas
dc.contributor.authorNOGUEIRA, Barbara Schwair
dc.contributor.authorAPARICIO, Luana Vanessa Marotti
dc.contributor.authorVERONEZI, Beatriz
dc.contributor.authorMORENO, Marina
dc.contributor.authorFERNANDES, Raquel Albano
dc.contributor.authorTAVARES, Diego
dc.contributor.authorBUENO, Priscila Vilela Silveira
dc.contributor.authorSEIBT, Ole
dc.contributor.authorBIKSON, Marom
dc.contributor.authorFRAGUAS, Renerio
dc.contributor.authorBENSENOR, Isabela Martins
dc.date.accessioned2015-10-26T16:31:58Z
dc.date.available2015-10-26T16:31:58Z
dc.date.issued2015
dc.description.abstractCONTEXT AND OBJECTIVE: Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study), which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in Sao Paulo, Brazil. METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3: 3: 2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging. RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS. CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.
dc.description.indexMEDLINE
dc.description.sponsorshipFAPESP Young Researcher grant from the Sao Paulo State Foundation (FAPESP) [20911-5]
dc.description.sponsorshipNARSAD Young Investigator grant from the Brain & Behavior Research Foundation [20493]
dc.description.sponsorshipNational Council for Scientific and Technological Development grant (CNPq) [470904]
dc.description.sponsorshipBrain & Behavior Research Foundation [20493]
dc.description.sponsorshipScientific Initiation fellowships from FAPESP [2013/19759-7, 2013/19566-4]
dc.description.sponsorshipCNPq
dc.identifier.citationSAO PAULO MEDICAL JOURNAL, v.133, n.3, p.252-263, 2015
dc.identifier.doi10.1590/1516-3180.2014.00351712
dc.identifier.issn1516-3180
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/11783
dc.language.isoeng
dc.publisherASSOCIACAO PAULISTA MEDICINA
dc.relation.ispartofSao Paulo Medical Journal
dc.rightsopenAccess
dc.rights.holderCopyright ASSOCIACAO PAULISTA MEDICINA
dc.subjectDepressive disorder
dc.subjectmajor
dc.subjectElectric stimulation therapy
dc.subjectCitalopram
dc.subjectRandomized controlled trial
dc.subjectBiological markers
dc.subject.otherdirect-current stimulation
dc.subject.othertranscranial magnetic stimulation
dc.subject.othersham-controlled trial
dc.subject.othertreatment-resistant depression
dc.subject.otherdorsolateral prefrontal cortex
dc.subject.othervoxel-based morphometry
dc.subject.otherserotonin 2a receptor
dc.subject.othermajor depression
dc.subject.otherdouble-blind
dc.subject.otherantidepressant treatment
dc.subject.wosMedicine, General & Internal
dc.titleThe Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial
dc.title.alternativeEstudo clínico Escitalopram versus Eletroterapia no Tratamento da Depressão (ELECT-TDCS): racional e desenho de estudo de um ensaio de não inferioridade, de três braços, placebo-controlado
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalMOFFA, Adriano Henrique:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalNOGUEIRA, Barbara Schwair:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalAPARICIO, Luana Vanessa Marotti:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalVERONEZI, Beatriz:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalFERNANDES, Raquel Albano:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalBUENO, Priscila Vilela Silveira:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalSEIBT, Ole:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalBIKSON, Marom:Univ Sao Paulo FMUSP, Fac Med, Sao Paulo, Brazil
hcfmusp.citation.scopus50
hcfmusp.contributor.author-fmusphcANDRE RUSSOWSKY BRUNONI
hcfmusp.contributor.author-fmusphcBERNARDO DE SAMPAIO PEREIRA JUNIOR
hcfmusp.contributor.author-fmusphcLUCAS BORRIONE
hcfmusp.contributor.author-fmusphcMARINA LOPES MORENO
hcfmusp.contributor.author-fmusphcDIEGO FREITAS TAVARES
hcfmusp.contributor.author-fmusphcRENERIO FRAGUAS JUNIOR
hcfmusp.contributor.author-fmusphcISABELA JUDITH MARTINS BENSEñOR
hcfmusp.description.beginpage252
hcfmusp.description.endpage263
hcfmusp.description.issue3
hcfmusp.description.volume133
hcfmusp.origemWOS
hcfmusp.origem.pubmed26176930
hcfmusp.origem.scieloSCIELO:S1516-31802015000300252
hcfmusp.origem.scopus2-s2.0-84937426363
hcfmusp.origem.wosWOS:000358015300012
hcfmusp.publisher.citySAO PAULO
hcfmusp.publisher.countryBRAZIL
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