Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: A multisite randomized controlled trial
Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: A multisite randomized controlled trial
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DOI：
10.1016/j.biopsych.2007.01.018
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发表时间：
2007-12-01
影响因子：
10.6
通讯作者：
Sackeim, Harold A.
中科院分区：
文献类型：
--
作者：
O'Reardon, John P.;Solvason, H. Brent;Sackeim, Harold A.
背景资料：我们测试是否经颅磁刺激（TMS）在左背外侧前额叶皮层（DLPFC）是有效的，安全的，在急性治疗的抑郁症。方法：在一项双盲，multisite的研究，301例药物治疗的抑郁症患者没有从先前的治疗中受益被随机分配到积极的（n = 155）或假TMS（n = 146）的条件。每周进行5次训练，TMS为10次脉冲/秒，运动阈值的120%，3000次脉冲/训练，持续4-6周。主要结局为第4周时使用蒙哥马利-艾斯伯格抑郁评定量表（MADRS）评估的症状评分变化。次要结果包括17项和24项汉密尔顿抑郁量表（HAMD）的变化和MADRS和HAMD.Results的反应和缓解率：主动TMS显着上级假TMS的MADRS在第4周（与事后校正组间基线症状严重程度的不平等），以及在HAMD 17和HAMD 24量表在第4周和第6周。在第4周和第6周，在所有三个量表上，主动TMS的应答率显著更高。第6周时，活动性TMS的缓解率约为2倍，并且在MADRS和HAMD 24量表（但不是HAMD 17量表）上具有显著性。主动TMS耐受性良好，不良事件（4.5%），一般是轻微的，仅限于短暂的头皮不适或pain.Conclusions：经颅磁刺激治疗抑郁症的副作用最小的低脱落率。它为临床医生提供了治疗这种疾病的新选择。
Background: We tested whether transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (DLPFC) is effective and safe in the acute treatment of major depression.Methods: In a double-blind, multisite study, 301 medication-free patients with major depression who had not benefited from prior treatment were randomized to active (n = 155) or sham TMS (n = 146) conditions. Sessions were conducted five times per week with TMS at 10 pulses/sec, 120% of motor threshold, 3000 pulses/session, for 4-6 weeks. Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD) and response and remission rates with the MADRS and HAMD.Results: Active TMS was significantly superior to sham TMS on the MADRS at week 4 (with a post hoc correction for inequality in symptom severity between groups at baseline), as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6. Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain.Conclusions: Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported. It offers clinicians a novel alternative for the treatment of this disorder.