title: 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.
abstract: 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).
  
  
  METHODS
  Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São 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.
  
  
  CONCLUSIONS
  Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.
authors.affiliation: Service of Interdisciplinary Neuromodulation, Laboratory of Neurosciences, Institute of Psychiatry, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: André Russowsky
authors.initials: AR
authors.lastname: Brunoni
authors.affiliation: Service of Interdisciplinary Neuromodulation, Laboratory of Neurosciences, Institute of Psychiatry, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Sampaio-Junior
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Adriano Henrique
authors.initials: AH
authors.lastname: Moffa
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Lucas
authors.initials: L
authors.lastname: Borrione
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Barbara Schwair
authors.initials: BS
authors.lastname: Nogueira
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Luana Vanessa Marotti
authors.initials: LV
authors.lastname: Aparício
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Veronezi
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Marina
authors.initials: M
authors.lastname: Moreno
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Raquel Albano
authors.initials: RA
authors.lastname: Fernandes
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Diego
authors.initials: D
authors.lastname: Tavares
authors.affiliation: Interdisciplinary Center for Applied Neuromodulation, HU, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Priscila Vilela Silveira
authors.initials: PV
authors.lastname: Bueno
authors.affiliation: Department of Biomedical Engineering, University of New York, New York, USA.
authors.forename: Ole
authors.initials: O
authors.lastname: Seibt
authors.affiliation: Department of Biomedical Engineering, University of New York, New York, USA.
authors.forename: Marom
authors.initials: M
authors.lastname: Bikson
authors.affiliation: Department and Institute of Psychiatry, HU, USP, São Paulo, Brazil.
authors.forename: Renerio
authors.initials: R
authors.lastname: Fraguas
authors.affiliation: HU, USP, São Paulo, Brazil.
authors.forename: Isabela Martins
authors.initials: IM
authors.lastname: Benseñor
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011569:Psychiatric Status Rating Scales; D015203:Reproducibility of Results; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram