Objective:

Depression is the leading cause of disability worldwide, and half of patients with depression have treatment-resistant depression. Intermittent theta-burst stimulation (iTBS) is approved by the U.S. Food and Drug Administration for the treatment of treatment-resistant depression but is limited by suboptimal efficacy and a 6-week duration. The authors addressed these limitations by developing a neuroscience-informed accelerated iTBS protocol, Stanford neuromodulation therapy (SNT; previously referred to as Stanford accelerated intelligent neuromodulation therapy, or SAINT). This protocol was associated with a remission rate of ∼90% after 5 days of open-label treatment. Here, the authors report the results of a sham-controlled double-blind trial of SNT for treatment-resistant depression.

Methods:

Participants with treatment-resistant depression currently experiencing moderate to severe depressive episodes were randomly assigned to receive active or sham SNT. Resting-state functional MRI was used to individually target the region of the left dorsolateral prefrontal cortex most functionally anticorrelated with the subgenual anterior cingulate cortex. The primary outcome was score on the Montgomery-Åsberg Depression Rating Scale (MADRS) 4 weeks after treatment.

Results:

At the planned interim analysis, 32 participants with treatment-resistant depression had been enrolled, and 29 participants who continued to meet inclusion criteria received either active (N=14) or sham (N=15) SNT. The mean percent reduction from baseline in MADRS score 4 weeks after treatment was 52.5% in the active treatment group and 11.1% in the sham treatment group.

Conclusions:

SNT, a high-dose iTBS protocol with functional-connectivity-guided targeting, was more effective than sham stimulation for treatment-resistant depression. Further trials are needed to determine SNT’s durability and to compare it with other treatments.

中文翻译：

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斯坦福神经调节疗法 (SNT)：一项双盲随机对照试验

客观的：

抑郁症是全球残疾的主要原因，一半的抑郁症患者患有难治性抑郁症。间歇性 theta-burst 刺激 (iTBS) 已被美国食品和药物管理局批准用于治疗难治性抑郁症，但受到疗效不佳和持续 6 周的限制。作者通过开发基于神经科学的加速 iTBS 协议、斯坦福神经调节疗法（SNT；以前称为斯坦福加速智能神经调节疗法或 SAINT）来解决这些限制。在开放标签治疗 5 天后，该方案与约 90% 的缓解率相关。在这里，作者报告了 SNT 治疗难治性抑郁症的假对照双盲试验的结果。

方法：

目前正在经历中度至重度抑郁发作的难治性抑郁症的参与者被随机分配接受主动或假 SNT。静息状态功能 MRI 用于单独针对与膝下前扣带皮层功能最不相关的左背外侧前额叶皮层区域。主要结果是治疗 4 周后蒙哥马利-埃斯伯格抑郁量表 (MADRS) 的评分。

结果：

在计划的中期分析中，已招募了 32 名患有难治性抑郁症的参与者，29 名继续满足纳入标准的参与者接受了主动（N=14）或假（N=15）SNT。治疗后 4 周，MADRS 评分从基线的平均下降百分比在积极治疗组和假治疗组分别为 52.5% 和 11.1%。

结论：

SNT 是一种具有功能连接引导靶向的高剂量 iTBS 协议，对于难治性抑郁症比假刺激更有效。需要进一步的试验来确定 SNT 的耐久性并将其与其他治疗方法进行比较。