Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression A Randomized Clinical Trial
Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression A Randomized Clinical Trial
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DOI：
10.1001/jamapsychiatry.2016.0152
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发表时间：
2016-05-01
期刊：
影响因子：
25.8
通讯作者：
Denys, Damiaan
中科院分区：
文献类型：
--
作者：
Bergfeld, Isidoor O.;Mantione, Mariska;Denys, Damiaan
治疗难治性抑郁症（TRD）患者对重度抑郁症的连续治疗反应不足。深部脑刺激（DBS）对这些患者来说是一种很有希望的治疗方法，但目前不能排除安慰剂效应。目的评价内囊腹前肢（vALIC） DBS的疗效，对照安慰剂效应和假刺激期。设计、环境和参与者：2010年3月22日至2014年5月8日，来自荷兰两家医院的25例TRD患者入组。患者首先进入52周的开放标签试验，在此期间，他们接受双侧4个接触电极植入，然后优化DBS，直到达到稳定的反应。一项随机,双盲,12周的交叉阶段进行接受积极治疗的病人紧随其后的是虚假的,反之亦然。使用意向-治疗分析确定对治疗的反应和无反应。干预措施针对vALIC的深部脑刺激。优化阶段分析的主要结果为17项汉密尔顿抑郁评定量表（HAM-D-17）的调查评分变化情况。交叉期的主要结果是主动DBS和假DBS之间HAM-D-17评分的差异。此工具的评分范围为0到52，分数越高表示症状越严重。患者被分为对治疗有反应（>=与基线相比HAM-D-17评分下降50%）和部分反应(>= 25，但
IMPORTANCE Patients with treatment-resistant depression (TRD) do not respond sufficiently to several consecutive treatments for major depressive disorder. Deep brain stimulation (DBS) is a promising treatment for these patients, but presently placebo effects cannot be ruled out.OBJECTIVE To assess the efficacy of DBS of the ventral anterior limb of the internal capsule (vALIC), controlling for placebo effects with active and sham stimulation phases.DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients with TRD from 2 hospitals in the Netherlands were enrolled between March 22, 2010, and May 8, 2014. Patients first entered a 52-week open-label trial during which they received bilateral implants of 4 contact electrodes followed by optimization of DBS until a stable response was achieved. A randomized, double-blind, 12-week crossover phase was then conducted with patients receiving active treatment followed by sham or vice versa. Response and nonresponse to treatment were determined using intention-to-treat analyses.INTERVENTIONS Deep brain stimulation targeted to the vALIC.MAIN OUTCOMES AND MEASURES The change in the investigator-rated score of the 17-item Hamilton Depression Rating Scale (HAM-D-17) was the main outcome used in analysis of the optimization phase. The primary outcome of the crossover phase was the difference in the HAM-D-17 scores between active and sham DBS. The score range of this tool is 0 to 52, with higher scores representing more severe symptoms. Patients were classified as responders to treatment (>= 50% decrease of the HAM-D-17 score compared with baseline) and partial responders (>= 25 but