Home-based transcranial direct current stimulation RCT in major depression

Abstract

Background Transcranial direct current stimulation (tDCS) has been proposed as a novel treatment in major depressive disorder (MDD). However, efficacy and safety of home-based tDCS treatment have not been investigated. Methods Fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of home-based tDCS treatment in MDD was conducted in UK and USA. Participants were adults 18 years or older, having MDD diagnosis based on DSM-5 criteria, in current depressive episode of at least moderate severity, measured by score >=16 on 17-item Hamilton Depression Rating Scale (HDRS), without treatment resistant depression history. Protocol was 10-week blinded phase: 5 tDCS sessions per week for 3 weeks then 3 sessions per week for 7 weeks; followed by 10-week open label phase. tDCS montage was bifrontal, 30-minute sessions, active tDCS 2 mA, and sham tDCS 0 mA with brief ramp up and down to mimic active device. Primary outcome was HDRS change at week 10 in modified intention-to-treat analysis. Results 174 MDD participants were randomized: active (n=87; mean age 37.1 + 11.1 years) and sham (n=87; mean age 38.3 + 10.9 years) treatment. Significant improvement in HDRS was observed in active (9.4 + 6.25 points) relative to sham treatment (7.1 + 6.10 points) (95% CI 0.5 to 4.0, p = 0.012), with no differences in discontinuation rates between active (n=13) and sham (n=12). Conclusions Home-based tDCS with remote supervision is a potential first line treatment for MDD that is acceptable and safe. Consideration of continuing effective safety monitoring is required. Trial registration numberNCT05202119