BACKGROUND:We compared transcranial direct-current stimulation (tDCS) with a selective serotonin-reuptake inhibitor for the treatment of depression. METHODS:In a single-center, double-blind, noninferiority trial involving adults with unipolar depression, we randomly assigned patients to receive tDCS plus oral placebo, sham tDCS plus escitalopram, or sham tDCS plus oral placebo. The tDCS was administered in 30-minute, 2-mA prefrontal stimulation sessions for 15 consecutive weekdays, followed by 7 weekly treatments. Escitalopram was given at a dose of 10 mg per day for 3 weeks and 20 mg per day thereafter. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS-17) score (range, 0 to 52, with higher scores indicating more depression). Noninferiority of tDCS versus escitalopram was defined by a lower boundary of the confidence interval for the difference in the decreased score that was at least 50% of the difference in the scores with placebo versus escitalopram. RESULTS:A total of 245 patients underwent randomization, with 91 being assigned to escitalopram, 94 to tDCS, and 60 to placebo. In the intention-to-treat analysis, the mean (±SD) decrease in the score from baseline was 11.3±6.5 points in the escitalopram group, 9.0±7.1 points in the tDCS group, and 5.8±7.9 points in the placebo group. The lower boundary of the confidence interval for the difference in the decrease for tDCS versus escitalopram (difference, -2.3 points; 95% confidence interval [CI], -4.3 to -0.4; P=0.69) was lower than the noninferiority margin of -2.75 (50% of placebo minus escitalopram), so noninferiority could not be claimed. Escitalopram and tDCS were both superior to placebo (difference vs. placebo, 5.5 points [95% CI, 3.1 to 7.8; P<0.001] and 3.2 points [95% CI, 0.7 to 5.5; P=0.01], respectively). Patients receiving tDCS had higher rates of skin redness, tinnitus, and nervousness than did those in the other two groups, and new-onset mania developed in 2 patients in the tDCS group. Patients receiving escitalopram had more frequent sleepiness and obstipation than did those in the other two groups. CONCLUSIONS:In a single-center trial, tDCS for the treatment of depression did not show noninferiority to escitalopram over a 10-week period and was associated with more adverse events. (Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo and others; ELECT-TDCS ClinicalTrials.gov number, NCT01894815 .).

译文

背景:我们比较了经颅直流电刺激(tDCS)和选择性5-羟色胺再摄取抑制剂治疗抑郁症的效果。
方法:在一项涉及成人单相抑郁症的单中心,双盲,非自卑性试验中,我们随机分配患者接受tDCS联合口服安慰剂,假tDCS联合依西酞普兰或假tDCS联合口服安慰剂。 tDCS在30分钟,2 mA的额前刺激中连续15个工作日进行给药,然后每周进行7次治疗。依西酞普兰的剂量为每天10 mg,持续3周,之后每天20 mg。主要结局指标是17个项目的汉密尔顿抑郁量表(HDRS-17)得分的变化(范围从0到52,得分越高表示抑郁越多)。 tDCS与依西酞普兰的非劣效性是由置信区间的下限定义的,即降低分数的差异至少是安慰剂与依西酞普兰分数差异的50%。
结果:共有245例患者接受了随机分组,其中91例患者被分配为依他普仑,94例被分配给tDCS,60例被分配给安慰剂。在意向性治疗分析中,依他普仑组的基线平均得分下降(±SD)为11.3±6.5分,tDCS组为9.0±7.1分,而安慰剂组为5.8±7.9分。 tDCS与依西酞普兰的降幅差异的置信区间的下限(差异-2.3点; 95%的置信区间[CI],-4.3至-0.4; P = 0.69)低于- 2.75(安慰剂减去艾司西酞普兰的50%),因此不能主张非自卑。 Escitalopram和tDCS均优于安慰剂(差异与安慰剂相比,分别为5.5分[95%CI,3.1至7.8; P <0.001]和3.2分[95%CI,0.7至5.5; P = 0.01]。接受tDCS的患者的皮肤发红,耳鸣和神经质发生率高于其他两组,并且tDCS组中的2例患者出现了新发躁狂症。接受艾司西酞普兰治疗的患者比其他两组患者更容易出现困倦和便秘。
结论:在一项单中心试验中,tDCS治疗抑郁症在10周内并未显示出依他普仑的非劣效性,并伴有更多不良事件。 (由圣保罗埃斯帕多萨基金会和圣保罗基金会资助; ELECT-TDCS ClinicalTrials.gov编号,NCT01894815。)。

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