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

Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSPBRUNONI, Andre RussowskySAMPAIO-JUNIOR, BernardoMOFFA, Adriano HenriqueBORRIONE, LucasNOGUEIRA, Barbara SchwairAPARICIO, Luana Vanessa MarottiVERONEZI, BeatrizMORENO, MarinaFERNANDES, Raquel AlbanoTAVARES, DiegoBUENO, Priscila Vilela SilveiraSEIBT, OleBIKSON, MaromFRAGUAS, RenerioBENSENOR, Isabela Martins2015-10-262015-10-262015SAO PAULO MEDICAL JOURNAL, v.133, n.3, p.252-263, 20151516-3180https://observatorio.fm.usp.br/handle/OPI/11783CONTEXT 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.engopenAccessDepressive disordermajorElectric stimulation therapyCitalopramRandomized controlled trialBiological markersdirect-current stimulationtranscranial magnetic stimulationsham-controlled trialtreatment-resistant depressiondorsolateral prefrontal cortexvoxel-based morphometryserotonin 2a receptormajor depressiondouble-blindantidepressant treatmentThe 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 trialEstudo 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-controladoarticleCopyright ASSOCIACAO PAULISTA MEDICINA10.1590/1516-3180.2014.00351712Medicine, General & Internal