Daily Left Prefrontal Transcranial Magnetic Stimulation Therapy for Major Depressive Disorder A Sham-Controlled Randomized Trial
Daily Left Prefrontal Transcranial Magnetic Stimulation Therapy for Major Depressive Disorder A Sham-Controlled Randomized Trial
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DOI：
10.1001/archgenpsychiatry.2010.46
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发表时间：
2010-05-01
影响因子：
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通讯作者：
Sackeim, Harold A.
中科院分区：
文献类型：
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作者：
George, Mark S.;Lisanby, Sarah H.;Sackeim, Harold A.
内容：每日左前额叶重复经颅磁刺激（rTMS）已被研究作为一种潜在的治疗抑郁症，但以前的工作有混合的结果，并没有充分掩盖sham conditions.Objective：为了测试是否每日左前额叶rTMS安全有效地治疗抑郁症。设计：前瞻性，多地点，随机，积极的假对照（1：1随机化），持续时间适应性设计，工作日每日治疗3周（固定剂量阶段），然后在改良剂中继续盲法治疗长达3周。设置：四所美国大学医院诊所。患者：大约860名门诊患者接受了筛选，产生了199名无抗抑郁药物的单相非精神病性重度抑郁症患者。我们以120%的运动阈值将rTMS输送到左前额叶皮层（10 Hz，4秒串持续时间和26秒串间间隔）持续37.5分钟（每次3000个脉冲）。Sham rTMS使用类似的线圈，带有阻挡磁场的金属插入物和提供匹配体感感觉的头皮电极。主要结果测量：在意向治疗样本（n=190）中，使用逻辑回归并控制当前抑郁发作的部位、治疗抵抗力、年龄和持续时间，比较了2个治疗组的缓解率。结果：患者、评估者和评分者均被有效掩蔽。最小的不良反应在治疗组之间没有差异，保留率为88%留存率（90%假手术组和86%活性药物组）。主要疗效分析显示，治疗对缓解者比例有显著影响（14.1%活性rTMS和5.1%假手术）（P=.02）。主动rTMS组获得缓解的几率是假手术组的4.2倍（95%置信区间，1.32-13.24）。需要治疗的人数为12人。大多数缓解者对抗抑郁药治疗的抵抗力较低。近30%的患者缓解的开放标签的后续行动（30.2%最初积极和29.6%假）。结论：每日左前额叶rTMS作为单一疗法产生的统计学显着和临床意义的抗抑郁治疗效果大于假。
Context: Daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) has been studied as a potential treatment for depression, but previous work had mixed outcomes and did not adequately mask sham conditions.Objective: To test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder.Design: Prospective, multisite, randomized, active sham-controlled (1: 1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers.Setting: Four US university hospital clinics.Patients: Approximately 860 outpatients were screened, yielding 199 antidepressant drug-free patients with unipolar nonpsychotic major depressive disorder.Intervention: We delivered rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.Main Outcome Measure: In the intention-to-treat sample (n=190), remission rates were compared for the 2 treatment arms using logistic regression and controlling for site, treatment resistance, age, and duration of the current depressive episode.Results: Patients, treaters, and raters were effectively masked. Minimal adverse effects did not differ by treatment arm, with an 88% retention rate (90% sham and 86% active). Primary efficacy analysis revealed a significant effect of treatment on the proportion of remitters (14.1% active rTMS and 5.1% sham) (P=.02). The odds of attaining remission were 4.2 times greater with active rTMS than with sham (95% confidence interval, 1.32-13.24). The number needed to treat was 12. Most remitters had low antidepressant treatment resistance. Almost 30% of patients remitted in the open-label follow-up (30.2% originally active and 29.6% sham).Conclusion: Daily left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham.