Comparison of blinding effectiveness between sham tDCS and placebo sertraline in a 6-week major depression randomized clinical trial

Autor(es)

Brunoni, Andre Russowsky ^{[1, 2]} ; Schestatsky, Pedro ^{[3, 4]} ; Lotufo, Paulo Andrade ^[1] ; Bensenor, Isabela Martins ^[1] ; Fregni, Felipe ^[5]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Fac Med, Ctr Clin & Epidemiol Res, Univ Hosp, Sao Paulo - Brazil

^[2] Univ Sao Paulo, Interdisciplinary Ctr Appl Neuromodulat, Univ Hosp, Sao Paulo - Brazil

^[3] Univ Fed Rio Grande do Sul, Dept Internal Med, Porto Alegre, RS - Brazil

^[4] Hosp Clin Porto Alegre, EMG Unit, Neurol Serv, Porto Alegre, RS - Brazil

^[5] Harvard Univ, Sch Med, Spaulding Rehabil Hosp, Lab Neuromodulat, Boston, MA - USA

• Tipo de documento: Artigo Científico
• Fonte: CLINICAL NEUROPHYSIOLOGY; v. 125, n. 2, p. 298-305, FEB 2014.
• Citações Web of Science: 38

Resumo

Objective: To compare blinding integrity and associated factors for transcranial direct current stimulation (tDCS) vs. placebo-pill, the gold standard blinding method. Methods: Parallel trial. Depressed participants were randomized to verum/placebo sertraline and active/sham tDCS (2 mA, 30-min 10-daily sessions and two additional, fortnight sessions) over 6 weeks. Blinding was assessed in completers (n = 102) and in a random subgroup (n = 35) of raters and participants, in which we also inquired to qualitatively describe their strongest guessing reason. Results: Participants and raters presented similar performance for predicting treatment assignment at endpoint, correctly guessing tDCS and sertraline beyond chance. Nevertheless, clinical response was associated with correct prediction and tDCS non-responders failed to predict the allocation group. For tDCS, ``trouble concentrating{''} was inversely associated with correct prediction. ``Skin redness{''} was more reported for active-tDCS, but did not predict the allocation group. The qualitative reasons for raters' guessing were not associated with correct prediction, whereas for participants clinical response and adverse effects were directly and inversely associated with correct prediction, respectively. Conclusion: Blinding integrity of tDCS and sertraline were comparable and mainly associated with efficacy rather than blinding failure. Significance: TDCS blinding can be improved by adopting parallel designs and avoiding subjects' awareness of skin redness. (C) 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved. (AU)

• Processo FAPESP: 12/20911-5 - Escitalopram e estimulação transcraniana por corrente contínua no transtorno depressivo maior: um ensaio clínico randomizado, duplo-cego, placebo-controlado de não-inferioridade
• Beneficiário: Andre Russowsky Brunoni
• Modalidade de apoio: Auxílio à Pesquisa - Jovens Pesquisadores
• Processo FAPESP: 09/05728-7 - Tratamento do transtorno depressivo maior com estimulação cerebral por corrente contínua: ensaio clínico, randomizado, duplo-cego, fatorial
• Beneficiário: Felipe Fregni
• Modalidade de apoio: Auxílio à Pesquisa - Regular