Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial-猫眼课题宝

DOI：

10.1001/jamapsychiatry.2017.4040

发表时间：

2017-12

期刊：

JAMA Psychiatry

影响因子：

25.8

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

B. Sampaio-Júnior;G. Tortella;Lucas Borrione;A. Moffa;R. Machado-Vieira;Eric Cretaz;Adriano Fernandes da Silva;R. Fráguas;L. V. Aparicio;Izio Klein;B. Lafer;S. Goerigk;I. Benseñor;P. Lotufo;W. Gattaz;A. Brunoni

重要性需要对双相情感障碍的治疗采取更有效、更耐受的干预措施。经颅直流电刺激(TDC)是一种新的治疗方式，严重不良反应少，对单相抑郁有良好的疗效。目的探讨TDCs作为双相抑郁辅助治疗的有效性和安全性。设计、设置和参与者从2014年7月1日到2016年3月30日，在门诊、单中心的学术环境中进行了一项随机、假对照、双盲试验(双相抑郁电疗试验[BECT])。参与者包括59名患有严重抑郁发作的I型或II型双相情感障碍的成年人，他们接受了稳定的药物治疗方案，17项汉密尔顿抑郁量表(HDRS-17)得分高于17。数据分析在意向治疗样本中进行。干预：活动或假性tDCs每天进行10次30分钟、2 mA、阳极左、阴阳极右前额叶训练，每两周1次，6周结束。结果59例患者(女性40例，占68%)，平均年龄45.9岁(12岁)，双相I型36例(61%)，双相II型23例(39%)，52例完成试验。在意向治疗分析中，处于活动状态的患者比接受假治疗的患者有显著的改善(INT=−1.68；需要治疗的数量，5.8；95%CI，3.3-25.8；P=.01)。与假手术组相比，活动组的累积有效率更高(67.6%比30.4%；需要治疗的次数，2.69；95%的可信区间，1.84-4.99；P=0.01)，但缓解率不高(37.4%比19.1%；需要治疗的次数，5.46；95%的可信区间，3.38-14.2；P=.18)。不良事件，包括治疗中出现的情感转换，两组之间相似，除了局部皮肤发红在活动组更高(54%比19%；P=.01)。结论和相关性：在这项试验中，对于这一小型双相抑郁样本，tDCS是一种有效、安全和可耐受的附加干预措施。进一步的试验应该在更大的样本中检验tdcs的有效性。临床试验注册.gov标识：NCT02152878

Importance More effective, tolerable interventions for bipolar depression treatment are needed. Transcranial direct current stimulation (tDCS) is a novel therapeutic modality with few severe adverse events that showed promising results for unipolar depression. Objective To determine the efficacy and safety of tDCS as an add-on treatment for bipolar depression. Design, Setting, and Participants A randomized, sham-controlled, double-blind trial (the Bipolar Depression Electrical Treatment Trial [BETTER]) was conducted from July 1, 2014, to March 30, 2016, at an outpatient, single-center academic setting. Participants included 59 adults with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen with 17-item Hamilton Depression Rating Scale (HDRS-17) scores higher than 17. Data were analyzed in the intention-to-treat sample. Interventions Ten daily 30-minute, 2-mA, anodal-left and cathodal-right prefrontal sessions of active or sham tDCS on weekdays and then 1 session every fortnight until week 6. Main Outcomes and Measures Change in HDRS-17 scores at week 6. Results Fifty-nine patients (40 [68%] women), with a mean (SD) age of 45.9 (12) years participated; 36 (61%) with bipolar I and 23 (39%) with bipolar II disorder were randomized and 52 finished the trial. In the intention-to-treat analysis, patients in the active tDCS condition showed significantly superior improvement compared with those receiving sham (int = −1.68; number needed to treat, 5.8; 95% CI, 3.3-25.8; P = .01). Cumulative response rates were higher in the active vs sham groups (67.6% vs 30.4%; number needed to treat, 2.69; 95% CI, 1.84-4.99; P = .01), but not remission rates (37.4% vs 19.1%; number needed to treat, 5.46; 95% CI, 3.38-14.2; P = .18). Adverse events, including treatment-emergent affective switches, were similar between groups, except for localized skin redness that was higher in the active group (54% vs 19%; P = .01). Conclusions and Relevance In this trial, tDCS was an effective, safe, and tolerable add-on intervention for this small bipolar depression sample. Further trials should examine tDCS efficacy in a larger sample. Trial Registration clinicaltrials.gov Identifier: NCT02152878

Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial

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