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 AND DESIGN: 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. DISCUSSION: 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.
RCT Entities:
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 AND DESIGN: 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, Val66MetBDNF polymorphism, and heart rate variability will also be examined. A neuropsychological battery with a focus on executive functioning will be administered. DISCUSSION: 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: Andre Russowsky Brunoni; Michael A Nitsche; Nadia Bolognini; Marom Bikson; Tim Wagner; Lotfi Merabet; Dylan J Edwards; Antoni Valero-Cabre; Alexander Rotenberg; Alvaro Pascual-Leone; Roberta Ferrucci; Alberto Priori; Paulo Sergio Boggio; Felipe Fregni Journal: Brain Stimul Date: 2011-04-01 Impact factor: 8.955
Authors: André R Brunoni; Rodrigo Machado-Vieira; Carlos A Zarate; Leandro Valiengo; Erica Lm Vieira; Isabela M Benseñor; Paulo A Lotufo; Wagner F Gattaz; Antonio L Teixeira Journal: Psychopharmacology (Berl) Date: 2013-10-23 Impact factor: 4.530
Authors: André R Brunoni; Rodrigo Machado-Vieira; Carlos A Zarate; Erica L M Vieira; Leandro Valiengo; Isabela M Benseñor; Paulo A Lotufo; Wagner F Gattaz; Antonio L Teixeira Journal: Prog Neuropsychopharmacol Biol Psychiatry Date: 2014-08-27 Impact factor: 5.067
Authors: André R Brunoni; Rodrigo Machado-Vieira; Carlos A Zarate; Erica L M Vieira; Marie-Anne Vanderhasselt; Michael A Nitsche; Leandro Valiengo; Isabela M Benseñor; Paulo A Lotufo; Wagner F Gattaz; Antonio L Teixeira Journal: Eur Neuropsychopharmacol Date: 2014-03-27 Impact factor: 4.600
Authors: Marom Bikson; Colleen A Hanlon; Adam J Woods; Bernadette T Gillick; Leigh Charvet; Claus Lamm; Graziella Madeo; Adrienn Holczer; Jorge Almeida; Andrea Antal; Mohammad Reza Ay; Chris Baeken; Daniel M Blumberger; Salvatore Campanella; Joan A Camprodon; Lasse Christiansen; Colleen Loo; Jennifer T Crinion; Paul Fitzgerald; Luigi Gallimberti; Peyman Ghobadi-Azbari; Iman Ghodratitoostani; Roland H Grabner; Gesa Hartwigsen; Akimasa Hirata; Adam Kirton; Helena Knotkova; Evgeny Krupitsky; Paola Marangolo; Ester M Nakamura-Palacios; Weronika Potok; Samir K Praharaj; Christian C Ruff; Gottfried Schlaug; Hartwig R Siebner; Charlotte J Stagg; Axel Thielscher; Nicole Wenderoth; Ti-Fei Yuan; Xiaochu Zhang; Hamed Ekhtiari Journal: Brain Stimul Date: 2020-05-12 Impact factor: 8.955
Authors: Daniel M Blumberger; Lisa C Tran; Paul B Fitzgerald; Kate E Hoy; Zafiris J Daskalakis Journal: Front Psychiatry Date: 2012-08-17 Impact factor: 4.157