From the Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27) (A.R.B., B.S.-J., L.B., L.V.M.A., R.F., W.F.G.), and the Interdisciplinary Center for Applied Neuromodulation, University Hospital (A.R.B., A.H.M., B.S.-J., L.B., M.L.M., R.A.F., B.P.V., B.S.N., L.V.M.A., L.B.R., R.C., L.C.T., R.F., P.A.L., I.M.B.), University of São Paulo, São Paulo; and the Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston (F.F.).
N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.
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 .).
背景：我们比较了经颅直流电刺激（tDCS）与选择性 5-羟色胺再摄取抑制剂治疗抑郁症的效果。
方法：在一项涉及单相抑郁症成年患者的单中心、双盲、非劣效性试验中，我们将患者随机分配接受 tDCS 加口服安慰剂、假 tDCS 加依地普仑或假 tDCS 加口服安慰剂治疗。tDCS 采用 2 mA、30 分钟的前额刺激，连续 15 天，随后进行 7 次每周治疗。依地普仑的起始剂量为每天 10 mg，此后增加至每天 20 mg。主要结局指标为汉密尔顿抑郁量表（HDRS-17）评分的变化（范围为 0 至 52 分，分数越高表示抑郁程度越严重）。tDCS 不劣于依地普仑的定义为，差值的置信区间下限至少为安慰剂与依地普仑差值的 50%。
结果：共有 245 名患者接受了随机分组，其中 91 名接受依地普仑治疗，94 名接受 tDCS 治疗，60 名接受安慰剂治疗。在意向治疗分析中，依地普仑组、tDCS 组和安慰剂组基线评分的平均（±SD）下降幅度分别为 11.3±6.5 分、9.0±7.1 分和 5.8±7.9 分。tDCS 与依地普仑差值的置信区间下限（差值，-2.3 点；95%CI，-4.3 至-0.4；P=0.69）低于非劣效性边界-2.75（安慰剂与依地普仑差值的 50%），因此不能声称 tDCS 具有非劣效性。依地普仑和 tDCS 均优于安慰剂（与安慰剂相比，差值分别为 5.5 点[95%CI，3.1 至 7.8；P<0.001]和 3.2 点[95%CI，0.7 至 5.5；P=0.01]）。接受 tDCS 治疗的患者皮肤发红、耳鸣和紧张的发生率高于其他两组，2 名 tDCS 组患者出现新发躁狂。接受依地普仑治疗的患者嗜睡和便秘的发生率高于其他两组。
结论：在一项单中心试验中，与依地普仑相比，10 周内 tDCS 治疗抑郁症未显示非劣效性，且不良反应更多。（由 São Paulo 州研究支持基金会和其他机构资助；ELECT-TDCS 临床试验。gov 注册号，NCT01894815）。
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