Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial - SELECT TDCS: Design, rationale and objectives

Author(s):Show less -

Brunoni, Andre Russowsky ^{[1, 2]} ; Valiengo, Leandro ^[3] ; Baccaro, Alessandra ; Zanao, Tamires Araujo ^[1] ; de Oliveira, Janaina Farias ^[1] ; Vieira, Giselly Pereira ; Bueno, Viviane Freire ^[1] ; Goulart, Alessandra C. ^[3] ; Boggio, Paulo Sergio ^{[4, 5]} ; Lotufo, Paulo Andrade ^[3] ; Bensenor, Isabela Martins ^[3] ; Fregni, Felipe ^{[6, 1]}

Affiliation

^[1] Univ Sao Paulo, Inst Psychol, Dept Neurosci & Behav, Sao Paulo - Brazil

^[2] Univ Sao Paulo, Inst Psychol, Univ Hosp, Clin Res Ctr, Sao Paulo - Brazil

^[3] Univ Sao Paulo, Sch Med, Sao Paulo - Brazil

^[4] Univ Prebiteriana Mackenzie, Cognit Neurosci Lab, Sao Paulo - Brazil

^[5] Univ Prebiteriana Mackenzie, Dev Disorders Program, Ctr Hlth & Biol Sci, Sao Paulo - Brazil

^[6] Harvard Univ, Sch Med, Lab Neuromodulat, Spaulding Rehabil Hosp, Boston, MA - USA

• Document type: Journal article
• Source: CONTEMPORARY CLINICAL TRIALS; v. 32, n. 1, p. 90-98, JAN 2011.
• Web of Science Citations: 37

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 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 6 weeks 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. (C) 2010 Elsevier Inc. All rights reserved. (AU)

• FAPESP's process: 09/05728-7 - A factorial, double-blinded, randomized clinical trial on major depressive disorder using transcranial direct current stimulation
• Grantee: Felipe Fregni
• Support Opportunities: Regular Research Grants