Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression
Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression
复制标题
DOI：
10.1056/nejmoa1612999
复制
发表时间：
2017-06-29
影响因子：
158.5
通讯作者：
Bensenor, I. M.
中科院分区：
文献类型：
--
作者：
Brunoni, A. R.;Moffa, A. H.;Bensenor, I. M.
背景：我们比较了经颅直流电刺激(TDC)和选择性5-羟色胺再摄取抑制剂治疗抑郁症的疗效。方法：在一项涉及成年单相抑郁症患者的单中心、双盲、非劣势试验中，我们随机分配患者接受TDC+口服安慰剂、假TDC+艾司匹林或假TDC+口服安慰剂。TDCS30分钟，2毫安，连续15个工作日进行额叶前部刺激，然后每周进行7次治疗。艾司匹兰10 mg/d，连服3周，以后20 mg/d。主要的结果衡量标准是17项汉密尔顿抑郁量表(HDRS-17)得分的变化(范围从0到52，得分越高表明抑郁越严重)。TDC与艾司匹兰的非劣势由降低评分差异的可信区间下限来定义，该下限至少是安慰剂与艾司匹兰评分差异的50%。结果共245名患者接受了随机化治疗，其中91人被分配给艾司匹兰，94人被分配给tDCs，60人被分配给安慰剂。在意向治疗分析中，依西替普兰组得分较基线平均下降(+/-SD)为11.3+/-6.5分，tDCS组为9.0+/-7.1分，安慰剂组为5.8+/-7.9分。Tdcs与艾司匹兰的降幅差异的可信区间下限(差值为-2.3分；95%可信区间[CI]，-4.3至-0.4；P=0.69)低于非劣势边界-2.75(安慰剂减去依西妥兰的50%)，因此不能声称非劣势。依西替普兰和tdcs均优于安慰剂(与安慰剂相比，差异为5.5分[95%CI，3.1至7.8；P
BACKGROUNDWe compared transcranial direct-current stimulation (tDCS) with a selective serotonin-reuptake inhibitor for the treatment of depression.METHODSIn 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.RESULTSA 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