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首页> 外文期刊>Archives of general psychiatry. >Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial.
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Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial.

机译：每天左前额经颅磁刺激治疗重度抑郁障碍:一个假对照随机试验。

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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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00149838.
机译：背景:每日左前额叶重复经颅磁刺激(rTMS)研究了作为一个潜在的治疗抑郁症,但是先前的结果喜忧参半,没有工作充分掩盖虚假的条件。测试日常左前额叶rTMS是否安全有效地治疗重度抑郁症。设计:前瞻性的多点随机,,活跃的假对照(1:1随机化),duration-adaptive设计3周的每天工作日治疗(固定剂量阶段)紧随其后另一个3继续盲目治疗周颠。医院诊所。门诊病人筛选,收益199抗抑郁药无毒单极患者nonpsychotic重度抑郁症。干预:我们交付rTMS向左前额叶皮层运动阈值120%(10赫兹,其次火车时间和26-second intertrain时间间隔为37.5分钟(3000脉冲/)使用一个8字形线圈实芯会话)。虚假的rTMS使用类似的用金属插入线圈屏蔽磁场和头皮电极交付与躯体感觉的感觉。主要结果测量:意向处理样本(n = 190),缓解率进行了比较2治疗武器的使用物流回归和控制网站,治疗电阻、年龄、和持续时间的电流抑郁发作。和评级机构有效地掩盖了。由治疗副作用没有差别的手臂,用一个虚假的保留率88%(90%和86%活跃)。显著影响治疗的比例虚假的缓解率(14.1%活跃rTMS和5.1%)(P= .02点)。与活跃rTMS倍而不是虚假的(95%置信区间,1.32 - -13.24)。需要治疗12岁。抗抑郁药物治疗抵抗。病人的非盲后续汇出(30.2%原本活跃和虚假的29.6%)。结论:日常左前额叶rTMS单一疗法产生统计上显著的临床上有意义的抗抑郁药治疗效果大于骗局。注册:clinicaltrials.gov标识符:

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