Conway Charles R, Rush A John, Gordon Charles, Preskorn Sheldon H, Sackeim Harold A, Aaronson Scott T, McIntyre Roger S, Lee Ying-Chieh Lisa, Shy Olivia, Tran Quyen, Way Jeffrey, Bunker Mark T
Department of Psychiatry, Washington University in St Louis, 600 South Taylor Ave, Suite 121, St Louis, MO 63110, USA.
Duke-NUS Medical School, 8 College Road, 169857, Singapore.
J Mood Anxiety Disord. 2025 Apr 14;10:100121. doi: 10.1016/j.xjmad.2025.100121. eCollection 2025 Jun.
The treatment of depression aims to improve depressive symptoms, daily function and quality of life (QoL). These exploratory analyses of a database of convenience from the RECOVER trial evaluated how a "tripartite" metric based on these 3 outcome domains might perform in treatment-resistant depression (TRD).
Outcome domains included depressive symptoms (MADRS, QIDS-C, QIDS-SR), function (WPAI item-6) and QoL (Mini-Q-LES-Q) obtained at months 3, 6, 9 and 12 in outpatients with markedly TRD in the double-blind RECOVER trial that compared sham to active adjunctive vagus nerve stimulation (VNS). For each domain, clinically meaningful differences were defined . Analyses addressed 3 questions: 1) Does each domain detect meaningful benefits undetected by the other domains? 2) Is the tripartite metric validated by an independent clinician-rated global index of improvement (CGI-I)? 3) How well does the tripartite metric detect treatment group differences in the RECOVER trial?
Clinically meaningful reductions in depressive symptoms alone missed 25-51 % of all participants who evidenced clinically meaningful benefits in depressive symptoms, function or QoL. The tripartite metric strongly correlated with CGI-I ratings (tetrachoric r = 0.73-0.85), with stronger relationships than each component individually. The tripartite metric successfully separated active from sham adjunctive VNS in a 1-year trial of patients with markedly TRD.
Symptoms, function and QoL capture distinct, clinically significant and valid outcomes that identify persons with markedly TRD with a range of clinically meaningful benefits. Whether these results pertain to other major depressive disorder patient groups and treatments deserves study.
抑郁症的治疗旨在改善抑郁症状、日常功能和生活质量（QoL）。这些对RECOVER试验便利数据库的探索性分析评估了基于这三个结果领域的“三方”指标在难治性抑郁症（TRD）中的表现。
结果领域包括在双盲RECOVER试验中，比较假刺激与主动辅助迷走神经刺激（VNS）的显著TRD门诊患者在第3、6、9和12个月时获得的抑郁症状（MADRS、QIDS-C、QIDS-SR）、功能（WPAI项目6）和QoL（Mini-Q-LES-Q）。对于每个领域，定义了具有临床意义的差异。分析涉及三个问题：1）每个领域是否能检测到其他领域未检测到的有意义的益处？2）三方指标是否通过独立的临床医生评定的总体改善指数（CGI-I）得到验证？3）三方指标在RECOVER试验中检测治疗组差异的效果如何？
仅抑郁症状有临床意义的减轻遗漏了所有在抑郁症状、功能或QoL方面有临床意义益处的参与者中的25%-51%。三方指标与CGI-I评分密切相关（四分相关系数r = 0.73 - 0.85），其关系比每个单独的成分更强。在一项针对显著TRD患者的1年试验中，三方指标成功地将主动辅助VNS与假刺激区分开来。
症状、功能和QoL捕捉到了不同的、具有临床意义且有效的结果，这些结果识别出了具有一系列临床意义益处的显著TRD患者。这些结果是否适用于其他重度抑郁症患者群体和治疗方法值得研究。
