The Sertraline vs Electrical Current Therapy for Treating Depression Clinical Study Results From a Factorial, Randomized, Controlled Trial
The Sertraline vs Electrical Current Therapy for Treating Depression Clinical Study Results From a Factorial, Randomized, Controlled Trial
复制标题
DOI：
10.1001/2013.jamapsychiatry.32
复制
发表时间：
2013-04-01
期刊：
影响因子：
25.8
通讯作者：
Fregni, Felipe
中科院分区：
文献类型：
--
作者：
Brunoni, Andre R.;Valiengo, Leandro;Fregni, Felipe
重要性：经颅直流电刺激（tDCS）治疗重度抑郁症（MDD）的试验显示出积极但好坏参半的结果。目的：评价tDCS与常用药物治疗（盐酸舍曲林，50 mg/d）的安全性和有效性。设计：双盲对照试验。参与者使用2 × 2因子设计随机分为舍曲林/安慰剂和主动/假性tDCS。地点：巴西圣保罗门诊，单中心学术机构。参与者：120名无抗抑郁药的中度至重度、非精神病性、单极MDD患者。干预措施：2- ma左/阴极右前额叶tDCS治疗6周（12次，每次30分钟，连续10次，周一至周五每天一次，每隔一周额外2次）和盐酸舍曲林（50 mg/d）。主要结局指标：在意向治疗分析中，主要结局指标是6周时Montgomery-Asberg抑郁评定量表评分的变化（终点）。我们认为至少3分的差异具有临床相关性。分析计划是先前发布的。安全性通过不良反应问卷、青年躁狂症评定量表和认知评估来测量。次要测量是临床反应率、缓解率和其他量表得分。结果：在主要终点，联合治疗组（舍曲林/活性tDCS）与单用舍曲林（平均差值8.5分，95% CI 2.96 ~ 14.03, P = 0.002）、单用tDCS（平均差值5.9分，95% CI 0.36 ~ 11.43, P = 0.03）和安慰剂/假tDCS（平均差值11.5分，95% CI 6.03 ~ 17.10, P < 0.001）比较，在Montgomery-Asberg抑郁评定量表得分上存在显著差异。仅tDCS与舍曲林的疗效比较（平均差异为2.6分；95% CI, -2.90至8.13;P = 0.35）。仅使用tDCS（但不仅使用舍曲林）优于安慰剂/假tDCS。常见的不良反应在干预之间没有差异，除了活动性tDCS中头皮皮肤发红（P = .03）。治疗后出现躁狂或轻躁狂7次，其中联合治疗组5次。结论及意义：在重度抑郁症中，tDCS联合舍曲林可提高各项治疗的疗效。tDCS与舍曲林的疗效和安全性无显著差异。
Importance: Transcranial direct current stimulation (tDCS) trials for major depressive disorder (MDD) have shown positive but mixed results.Objective: To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment (sertraline hydrochloride, 50 mg/d).Design: Double-blind, controlled trial. Participants were randomized using a 2 x 2 factorial design to sertraline/placebo and active/sham tDCS.Setting: Outpatient, single-center academic setting in Sao Paulo, Brazil.Participants: One hundred twenty antidepressant free patients with moderate to severe, nonpsychotic, unipolar MDD.Interventions: Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS (twelve 30-minute sessions: 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week) and sertraline hydrochloride (50 mg/d).Main Outcome Measures: In this intention-to-treat analysis, the primary outcome measure was the change in Montgomery-Asberg Depression Rating Scale score at 6 weeks (end point). We considered a difference of at least 3 points to be clinically relevant. The analysis plan was previously published. Safety was measured with an adverse effects questionnaire, the Young Mania Rating Scale, and cognitive assessment. Secondary measures were rates of clinical response and remission and scores on other scales.Results: At the main end point, there was a significant difference in Montgomery-Asberg Depression Rating Scale scores when comparing the combined treatment group (sertraline/active tDCS) vs sertraline only (mean difference, 8.5 points; 95% CI, 2.96 to 14.03; P = .002), tDCS only (mean difference, 5.9 points; 95% CI, 0.36 to 11.43; P = .03), and placebo/sham tDCS (mean difference, 11.5 points; 95% CI, 6.03 to 17.10; P < .001). Analysis of tDCS only vs sertraline only presented comparable efficacies (mean difference, 2.6 points; 95% CI, -2.90 to 8.13; P = .35). Use of tDCS only (but not sertraline only) was superior to placebo/sham tDCS. Common adverse effects did not differ between interventions, except for skin redness on the scalp in active tDCS (P = .03). There were 7 episodes of treatment-emergent mania or hypomania, 5 occurring in the combined treatment group.Conclusions and Relevance: In MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ.