Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives.
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.
Brunoni
Andre Russowsky
AR
Clinical Research Center, University Hospital, University of São Paulo, Brazil. brunoni@usp.br
Valiengo
Leandro
L
Baccaro
Alessandra
A
Zanao
Tamires Araujo
TA
de Oliveira
Janaina Farias
JF
Vieira
Giselly Pereira
GP
Bueno
Viviane Freire
VF
Goulart
Alessandra C
AC
Boggio
Paulo Sérgio
PS
Lotufo
Paulo Andrade
PA
Bensenor
Isabela Martins
IM
Fregni
Felipe
F
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
D000928:Antidepressive Agents; D020280:Sertraline