Sertraline vs. Electrical Current Therapy for Treating Depression Clinical Trial (SELECT TDCS): Results from a Factorial, Randomized, Controlled Trial

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conferenceObject
Data de publicação
2012
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ELSEVIER SCIENCE INC
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BIOLOGICAL PSYCHIATRY, v.71, n.8, suppl.S, p.57S-57S, 2012
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Background: Non-invasive brain stimulation has been increasingly used as an intervention for major depressive disorder (MDD). Methods: Randomized, factorial, double-blinded, controlled trial. Participants were randomized to sertraline/placebo and active/sham tDCS. They presented moderate to severe medication-free, nonpsychotic, unipolar, major depressivedisorder. They received 6-week treatment of 2mA anodal left dorsolateral prefrontal tDCS (twelve 30-min sessions: 10 consecutive sessions plus two extra sessions every other week) and sertraline (50mg/day). The primary outcome was the Montgomery-Asberg depression scale (MADRS) score changes at the end of treatment (6-week). A difference of at least 3 points in scores was consideredclinically relevant. Secondary outcomes were remission and response rates, and other depression scales. Results : At six weeks (primary outcome), the combined treatment was superior to sham tDCS - placebo (mean difference= 11.5 points; 95% CI=6.03 to 17.1; p<0.01) to sham tDCS -sertraline (mean 8.5; 95% CI=2.96 to 14.03; p<0.01) and to active tDCS - placebo (mean 5.9; 95%=CI 0.36 to 11.43). TDCS and sertraline alone were not different between each other (mean 2.6; 95% CI=8.13 to -2.9; p=0.35). Secondary efficacy analyses mainly confirmed these findings. Adverse effects were not significantly different when comparing groups, althoughfive of seven episodes of treatment-emergent (hypo)mania were observed in the combined treatment. Conclusions: In MDD, combination of tDCS and sertraline increases the efficacy of each treatment alone. Efficacy/safety did not differ between them.
Palavras-chave
transcranial direct current stimulation, major depressive disorder, sertraline, randomized clinical trial, factorial design