低频重复经颅磁刺激治疗对抗抑郁药无反应的双相抑郁的疗效：一项单盲随机假对照试验
Antidepressant efficacy of low-frequency repetitive transcranial magnetic stimulation in antidepressant-nonresponding bipolar depression: a single-blind randomized sham-controlled trial.
作者信息
Mak Arthur D P, Neggers Sebastiaan F W, Leung Owen N W, Chu Winnie C W, Ho Jenny Y M, Chou Idy W Y, Chan Sandra S M, Lam Linda C W, Lee Sing
机构信息
Department of Psychiatry, The Chinese University of Hong Kong, G/F Multicentre, Tai Po Hospital, Tai Po, Hong Kong, SAR, China.
Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
出版信息
Int J Bipolar Disord. 2021 Dec 8;9(1):40. doi: 10.1186/s40345-021-00245-1.
BACKGROUND
To examine the antidepressant efficacy and response predictors of R-DLPFC-LF rTMS for antidepressant-nonresponding BD.
METHODS
We conducted a single-blind randomized sham-controlled trial for 54 (28 sham, 26 active) patients with antidepressant-nonresponding BD (baseline MADRS ≥ 20). Patients received 15 daily sessions of active or sham neuronavigated rTMS (Figure-of-8 coil, five 1 Hz 60 s 110% RMT trains). Outcome measures included depressive response (≥ 50% MADRS reduction, CGI ≤ 2) and remission (MADRS < 7, CGI = 1) rates, treatment emergent hypo/mania (YMRS), depressive and anxiety symptoms (HAM-A).
RESULTS
48 patients (25 sham, 23 active) completed treatment, with 3 drop-outs each in active and sham groups. Active rTMS did not produce superior response or remission rates at endpoint or 6 or 12 weeks (ps > 0.05). There was no significant group * time interaction (ps > 0.05) in a multivariate ANOVA with MADRS, HAMA and YMRS as dependent variables. Exploratory analysis found MADRS improvement to be moderated by baseline anxiety (p = 0.02) and melancholia (p = 0.03) at week 3, and depressive onset at weeks 6 (p = 0.03) and 12 (p = 0.04). In subjects with below-mean anxiety (HAMA < 20.7, n = 24), MADRS improvement from active rTMS was superior to sham at week 3 (ITT, t = 2.49, p = 0.04, Cohen's d = 1.05). No seizures were observed. Groups did not differ in treatment-emergent hypomania (p = 0.1).
LIMITATIONS
Larger sample size might be needed to power subgroup analyses. Moderation analyses were exploratory. Single-blind design. Unblinding before follow-up assessments due to ethical reasons.
CONCLUSIONS
1-Hz 110% RMT (5 × 60 s trains) R-DLPFC-LF rTMS was not effective for antidepressant non-responding BD but may be further investigated at increased dosage and/or in BD patients with low anxiety. Trial registration CCRB Clinical Trials Registry, CUHK, CUHK_CCT00440. Registered 04 December 2014, https://www2.ccrb.cuhk.edu.hk/registry/public/279.
背景
探讨右侧背外侧前额叶-左侧额叶重复经颅磁刺激（R-DLPFC-LF rTMS）对抑郁治疗无反应的双相情感障碍（BD）患者的抗抑郁疗效及反应预测因素。
方法
我们对54例（28例假刺激，26例真刺激）抑郁治疗无反应的BD患者（基线蒙哥马利-艾森伯格抑郁量表[MADRS]≥20）进行了一项单盲随机假刺激对照试验。患者每天接受15次真刺激或假刺激的神经导航rTMS治疗（8字形线圈，5组1赫兹、60秒、110%静息运动阈值[RMT]的序列）。疗效指标包括抑郁反应（MADRS降低≥50%，临床总体印象量表[CGI]≤2）和缓解率（MADRS<7，CGI=1）、治疗中出现的轻躁狂（杨氏躁狂量表[YMRS]）、抑郁和焦虑症状（汉密尔顿焦虑量表[HAM-A]）。
结果
48例患者（25例假刺激，23例真刺激）完成治疗，真刺激组和假刺激组各有3例退出。在终点、6周或12周时，真刺激rTMS并未产生更高的反应率或缓解率（p>0.05）。在以MADRS、HAM-A和YMRS为因变量的多因素方差分析中，不存在显著的组*时间交互作用（p>0.05）。探索性分析发现，在第3周时，MADRS的改善受到基线焦虑（p=0.02）和抑郁性（p=0.03）的调节，在第6周（p=0.03）和12周（p=0.04）时受到抑郁发作的调节。在焦虑水平低于均值（HAM-A<20.7，n=24）的受试者中，第3周时真刺激rTMS带来的MADRS改善优于假刺激（意向性分析，t=2.49，p=0.04，科恩d值=1.05）。未观察到癫痫发作。两组在治疗中出现的轻躁狂方面无差异（p=0.1）。
局限性
可能需要更大样本量以支持亚组分析。调节分析为探索性的。单盲设计。出于伦理原因，在随访评估前解除盲法。
结论
1赫兹、110%RMT（5×60秒序列）的R-DLPFC-LF rTMS对抑郁治疗无反应的BD患者无效，但可在增加剂量和/或在低焦虑的BD患者中进一步研究。试验注册：香港中文大学临床研究伦理委员会临床试验注册中心，CUHK_CCT00440。2014年12月4日注册，https://www2.ccrb.cuhk.edu.hk/registry/public/279。
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