Vieta Eduard, Ahmed Nahida, Arango Celso, Cleare Anthony J, Demyttenaere Koen, Dold Markus, Ito Tetsuro, Kambarov Yerkebulan, Krüger Stephanie, Llorca Pierre-Michel, McIntyre Roger S, Sani Gabriele, von Holt Christian, Rive Benoit
Institute of Neuroscience, University of Barcelona, Hospital Clinic, IDIBAPS, CIBERSAM, Barcelona, Spain.
Sakina Mental Health & Wellbeing Services, College of Medicine, and Health Sciences (CMHS) of the United Arab Emirates University, Khalifa University, Abu Dhabi, United Arab Emirates.
Eur Neuropsychopharmacol. 2025 Apr;93:29-39. doi: 10.1016/j.euroneuro.2024.12.013. Epub 2025 Feb 8.
Patients with treatment resistant depression (TRD) experience a greater negative impact on their functioning and productivity at home and in the workplace versus treatment-responsive patients. Here, we report the effects of esketamine nasal spray (NS) versus quetiapine extended release (XR) on functioning, work productivity and activity impairment. ESCAPE‑TRD (NCT04338321) was a 32-week randomised, open‑label, rater‑blinded, active‑controlled phase IIIb study comparing the efficacy and safety of esketamine NS versus quetiapine XR, both alongside an ongoing selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor (SSRI/SNRI), in patients with TRD. Patient functioning was assessed via the Sheehan Disability Scale (SDS; functional remission ≤6). Absenteeism, presenteeism, work productivity loss and activity impairment over time were assessed using the Work Productivity and Activity Impairment: Depression (WPAI:D) questionnaire. Results were cumulated over the entire study duration. Esketamine NS-treated patients (N = 336) experienced 43.2 % more weeks with functional remission versus quetiapine XR-treated patients (N = 340) over the 32-week study period (difference: 2.0 weeks [95 % CI: 0.7, 3.3]; p = 0.0023 [ANCOVA models]). Up to Week 32, esketamine NS-treated patients experienced an 11.9 % reduction in productivity loss due to absenteeism (difference: -1.1 weeks [95 % CI: -2.9, 0.7]; p = 0.2285) and a 14.2 % reduction in overall work productivity loss (difference: -2.3 weeks, 95 % CI: [-3.9, -0.7] p = 0.0045) versus quetiapine XR-treated patients, based on mixed models for repeated measures. Patients receiving esketamine NS experienced greater improvements in functioning and productivity over 32 weeks versus quetiapine XR. These improvements demonstrate the clinical and functional benefit of treatment with esketamine NS for patients with TRD.
与治疗反应良好的患者相比，难治性抑郁症（TRD）患者在家庭和工作场所的功能及生产力受到的负面影响更大。在此，我们报告了艾氯胺酮鼻喷雾剂（NS）与喹硫平缓释剂（XR）对功能、工作生产力和活动障碍的影响。ESCAPE-TRD（NCT04338321）是一项为期32周的随机、开放标签、评估者盲法、活性对照的IIIb期研究，比较了艾氯胺酮NS与喹硫平XR在TRD患者中的疗效和安全性，两者均与正在使用的选择性5-羟色胺再摄取抑制剂或5-羟色胺去甲肾上腺素再摄取抑制剂（SSRI/SNRI）联合使用。通过希恩残疾量表（SDS；功能缓解≤6）评估患者功能。使用工作生产力和活动障碍：抑郁症（WPAI:D）问卷评估随时间推移的旷工、出勤、工作生产力损失和活动障碍。结果在整个研究期间进行累积。在32周的研究期内，接受艾氯胺酮NS治疗的患者（N = 336）功能缓解的周数比接受喹硫平XR治疗的患者（N = 340）多43.2%（差异：2.0周[95%CI：0.7，3.3]；p = 0.0023[协方差分析模型]）。根据重复测量的混合模型，至第32周时，与接受喹硫平XR治疗的患者相比，接受艾氯胺酮NS治疗的患者因旷工导致的生产力损失降低了11.9%（差异：-1.1周[95%CI：-2.9，0.7]；p = 0.2285），总体工作生产力损失降低了14.2%（差异：-2.3周，95%CI：[-3.9，-0.7]，p = 0.004）。与喹硫平XR相比，接受艾氯胺酮NS治疗的患者在32周内功能和生产力有更大改善。这些改善证明了艾氯胺酮NS治疗对TRD患者的临床和功能益处。
