Transcranial direct current stimulation (tDCS) has been proposed as a new treatment in major depressive disorder (MDD). This is a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured using the Hamilton Depression Rating Scale (mean = 19.07 ± 2.73). A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95% confidence interval = 0.51–4.01, P = 0.012). There were no differences in discontinuation rates. In summary, a 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety. ClinicalTrials.gov registration: NCT05202119

经颅直流电刺激 （tDCS） 已被提议作为重度抑郁症 （MDD） 的新治疗方法。这是一项完全远程、多中心、双盲、安慰剂对照、随机优效性试验，针对 MDD 中为期 10 周的家庭 tDCS。参与者年龄在 18 岁或以上，使用汉密尔顿抑郁量表测量的当前抑郁发作至少为中度严重程度的 MDD（平均值 = 19.07 ± 2.73）。共有 174 名参与者 （120 名女性，54 名男性） 被随机分配到积极治疗组 （n = 87，平均年龄 = 37.09 ± 11.14 岁） 或假治疗 （n = 87，平均年龄 = 38.32 ± 10.92 岁） 治疗。tDCS 包括每周 5 次治疗，持续 3 周，然后每周 3 次治疗，持续 7 周，为期 10 周的试验，然后是 10 周的开放标签阶段。每节课持续 30 分钟;阳极放置在左背外侧前额叶皮层上，阴极放置在右背外侧前额叶皮层上（主动 tDCS 2 mA 和假 tDCS 0 mA，短暂的上升和下降以模拟主动刺激）。作为主要结果，使用汉密尔顿抑郁量表测量时，抑郁症状显示出显着改善：主动 9.41 ± 6.25 分改善（10 周平均值 = 9.58 ± 6.02）和假 7.14 ± 6.10 分改善（10 周平均值 = 11.66 ± 5.96）（95% 置信区间 = 0.51-4.01，P = 0.012）。 停药率没有差异。总之，在 MDD 中进行为期 10 周的家庭远程监督 tDCS 治疗显示出高疗效、可接受性和安全性。ClinicalTrials.gov 注册：NCT05202119