title: Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives.
abstract: BACKGROUND
  Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with tools of non-invasive brain stimulation - such as transcranial magnetic stimulation and transcranial direct current stimulation (tDCS). Due to its profile, tDCS seems to be a safe and affordable approach.
  
  
  METHODS
  The SELECT TDCS trial aims to compare sertraline vs. tDCS in a double-blinded, randomized, factorial trial enrolling 120 participants to be allocated to four groups to receive sertraline+tDCS, sertraline, tDCS or placebo. Eligibility criteria are moderate-to-severe unipolar depression (Hamilton Depression Rating Scale >17) not currently on sertraline treatment. Treatment will last 6weeks and the primary outcome is depression change in the Montgomery-Asberg Depression Rating Score (MADRS). Potential biological markers that mediate response, such as BDNF serum levels, Val66Met BDNF polymorphism, and heart rate variability will also be examined. A neuropsychological battery with a focus on executive functioning will be administered.
  
  
  CONCLUSIONS
  With this design we will be able to investigate whether tDCS is more effective than placebo in a sample of patients free of antidepressants and in addition, we will be able to secondarily compare the effect sizes of sertraline vs. tDCS and also the comparison between tDCS and combination of tDCS and sertraline.
authors.affiliation: Clinical Research Center, University Hospital, University of São Paulo, Brazil. brunoni@usp.br
authors.forename: Andre Russowsky
authors.initials: AR
authors.lastname: Brunoni
authors.forename: Leandro
authors.initials: L
authors.lastname: Valiengo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Baccaro
authors.forename: Tamires Araujo
authors.initials: TA
authors.lastname: Zanao
authors.forename: Janaina Farias
authors.initials: JF
authors.lastname: de Oliveira
authors.forename: Giselly Pereira
authors.initials: GP
authors.lastname: Vieira
authors.forename: Viviane Freire
authors.initials: VF
authors.lastname: Bueno
authors.forename: Alessandra C
authors.initials: AC
authors.lastname: Goulart
authors.forename: Paulo Sérgio
authors.initials: PS
authors.lastname: Boggio
authors.forename: Paulo Andrade
authors.initials: PA
authors.lastname: Lotufo
authors.forename: Isabela Martins
authors.initials: IM
authors.lastname: Bensenor
authors.forename: Felipe
authors.initials: F
authors.lastname: Fregni
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D002540:Cerebral Cortex / Q000502:physiology / Q000503:physiopathology; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000379:methods*; D006801:Humans; D012107:Research Design; D020280:Sertraline / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D020280:Sertraline