We compared the efficacy and safety of transcranial direct current stimulation (tDCS) vs. Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants. This was a multi-center, double blind, active controlled study with non-inferiority testing. Patients were randomly assigned to receive tDCS (n = 45) or Sertraline (n = 47). tDCS was administered in 30-min, 2 mA prefrontal stimulation sessions for 10 consecutive weekdays, followed by 2 treatments at 4 and 6 weeks. Sertraline was administered at a dose of 50 mg per day for 6 weeks. The primary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. Mean MADRS scores decreased by 14.58 ± 8.51 points in the tDCS group and 12.32 ± 8.56 points in the Sertraline group. There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539). Noninferiority of tDCS compared with Sertraline was not demonstrated. The mean difference between the Sertraline and tDCS group was −2.258 (95% confidence interval [CI], −5.795 to 1.27811), and the lower boundary of the CI was lower than the prespecified noninferiority margin of −3.56. There were no significant group differences in the rate of adverse events. In the present study, the noninferiority of tDCS to Sertraline for the treatment of depression was not found in this Korean population.

我们比较了经颅直流电刺激（tDCS）和舍曲林治疗韩国抑郁症患者的重度抑郁症的疗效和安全性。这是一项多中心，双盲，主动对照研究，包括非自卑性测试。患者被随机分配接受tDCS（n = 45）或Sertraline（n = 47）。在30分钟，2 mA的前额叶刺激疗程中连续10个工作日施用tDCS，然后在4周和6周进行2次治疗。舍曲林以每天50 mg的剂量给药，持续6周。主要结局指标是六周时蒙哥马利-阿斯伯格抑郁量表（MADRS）得分的变化。tDCS组的平均MADRS得分降低了14.58±8.51分，而舍曲林组的平均MADRS得分降低了12.32±8.56分。组没有显着的主要作用（p = 0。5877）或第0、3和6周的小组互动时间（p = 0.1539）。没有证实tDCS与Sertraline相比具有非劣效性。舍曲林和tDCS组之间的平均差为-2.258（95％置信区间[CI]，-5.795至1.27811），CI的下边界低于-3.56的预定非劣效性余量。不良事件发生率在各组之间无显着差异。在本研究中，在该韩国人群中未发现tDCS优于舍曲林治疗抑郁症。CI的下边界低于-3.56的预定的非劣效性余量。不良事件发生率在各组之间无显着差异。在本研究中，在该韩国人群中未发现tDCS优于舍曲林治疗抑郁症。CI的下边界低于-3.56的预定的非劣效性余量。不良事件发生率在各组之间无显着差异。在本研究中，在该韩国人群中未发现tDCS优于舍曲林治疗抑郁症。