OBJECTIVE Deep brain stimulation (DBS) reduces depressive symptoms in approximately 40%-60% of patients with treatment-resistant depression (TRD), but data on long-term efficacy and safety are scarce. Our objective was to assess the efficacy and safety of DBS targeted at the ventral anterior limb of the internal capsule (vALIC) in 25 patients with TRD during a 1-year, open-label, maintenance period, which followed a 1-year optimisation period. METHODS Depression severity was measured using the 17-item Hamilton Depression Rating Scale (HAM-D-17), Montgomery-Asberg Depression Rating Scale (MADRS) and self-reported Inventory of Depressive Symptomatology (IDS-SR). Primary outcomes were response rate (≥50% HAM-D-17 score reduction) after the maintenance phase, approximately 2 years after DBS surgery, and changes in depression scores and occurrence of adverse events during the maintenance phase. RESULTS Of 25 operated patients, 21 entered and 18 completed the maintenance phase. After the maintenance phase, eight patients were classified as responder (observed response rate: 44.4%; intention-to-treat: 32.0%). During the maintenance phase, HAM-D-17 and MADRS scores did not change, but the mean IDS-SR score decreased from 38.8 (95% CI 31.2 to 46.5) to 35.0 (95% CI 26.1 to 43.8) (p=0.008). Non-responders after optimisation did not improve during the maintenance phase. Four non-DBS-related serious adverse events occurred, including one suicide attempt. CONCLUSIONS vALIC DBS for TRD showed continued efficacy 2 years after surgery, with symptoms remaining stable after optimisation as rated by clinicians and with patient ratings improving. This supports DBS as a viable treatment option for patients with TRD. TRIAL REGISTRATION NUMBER NTR2118.

中文翻译：

---

长期深部大脑刺激内囊腹侧前肢用于治疗难治性抑郁症。

目的深部脑刺激（DBS）可以减轻约40％-60％的耐药性抑郁症（TRD）患者的抑郁症状，但缺乏长期疗效和安全性的数据。我们的目的是评估在25年的TRD患者中，在为期1年的开放标签维护期间（随后为期1年的优化期），评估针对内囊腹侧前肢（vALIC）的DBS的有效性和安全性。方法使用17项汉密尔顿抑郁量表（HAM-D-17），蒙哥马利-阿斯伯格抑郁量表（MADRS）和自我报告的抑郁症状量表（IDS-SR）测量抑郁的严重程度。主要结局为维持期后（DBS手术后约2年）的缓解率（HAM-D-17得分降低≥50％），在维持阶段抑郁指数的变化和不良事件的发生。结果在25例手术患者中，有21例进入手术，18例完成了维持治疗阶段。维持阶段后，将8例患者归为有反应者（观察到的有效率：44.4％；有意治疗：32.0％）。在维护阶段，HAM-D-17和MADRS得分没有变化，但IDS-SR的平均得分从38.8（95％CI 31.2降至46.5）降至35.0（95％CI 26.1降至43.8）（p = 0.008） 。优化后的无响应者在维护阶段没有得到改善。发生了四起与星展银行无关的严重不良事件，其中包括一例自杀未遂。结论vALIC DBS TRD术后2年显示出持续的疗效，经过临床医生评估，症状在优化后仍保持稳定，并且患者的评分有所改善。这支持DBS作为TRD患者的可行治疗选择。试用注册号NTR2118。