:Objective:To assess health-related quality of life (HRQoL) and health status of patients with treatment resistant depression (TRD), treated with esketamine nasal spray+oral antidepressant (ESK+AD) vs oral antidepressant+placebo nasal spray (AD+PBO) using European Quality of Life Group-5-Dimension-5-Level (EQ-5D-5L). The EQ-5D-5L descriptive system consists of five domains relevant for patients with depression (mobility, self-care, usual activities, pain, anxiety/depression) and the EQ-Visual Analogue Scale (EQ-VAS).Methods:Data from TRANSFORM-2 (NCT02418585), a randomized, double-blind short-term study were analyzed. Patients (18-64 years inclusive) with TRD were included. Patient reported health status change using EQ-5D-5L and EQ-VAS was measured from baseline to end of 4-week induction phase (endpoint). Each domain of EQ-5D-5L included 5 levels of perceived problems (L1: no problems; L5: extreme problems).Results:Full analysis set included 223 patients (ESK+AD: 114; AD+PBO: 109). At endpoint, mean (SD) change in health status index was 0.288 (0.2317) for ESK+AD group and 0.231 (0.2506) for AD+PBO group with higher score reflecting higher levels of functioning. At endpoint, percentage of patients reporting problems (grouped L2-L5 responses for each dimension) in ESK+AD vs AD+PBO group: mobility (13.5% vs 25.7%), self-care (16.2% vs 30.5%), usual activities (55.0% vs 71.4%), pain (38.7% vs 52.4%), and anxiety/depression (71.2% vs 78.1%). Mean (SD) change in EQ-VAS score at endpoint was 29.1 (26.32) for ESK+AD and 20.9 (26.60) for AD+PBO group.Conclusion:Greater improvement in HRQoL and health status using EQ-5D-5L and EQ-VAS was observed among patients with TRD treated with ESK+AD vs AD+PBO.Funding Acknowledgements:This study was sponsored by Janssen Research and Development, LLC.

中文翻译：

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119 难治性抑郁症患者健康相关生活质量和健康状况的评估

：目的：评估接受艾氯胺酮鼻喷雾剂+口服抗抑郁药（ESK+AD）与口服抗抑郁药+安慰剂鼻喷雾剂（AD+）治疗难治性抑郁症（TRD）患者的健康相关生活质量（HRQoL）和健康状况PBO) 使用欧洲生活质量组 5-Dimension-5-Level (EQ-5D-5L)。EQ-5D-5L 描述系统由与抑郁症患者相关的五个领域（活动能力、自我保健、日常活动、疼痛、焦虑/抑郁）和 EQ-视觉模拟量表 (EQ-VAS) 组成。方法：数据来自TRANSFORM-2 (NCT02418585) 是一项随机、双盲的短期研究。包括患有 TRD 的患者（包括 18-64 岁）。使用 EQ-5D-5L 和 EQ-VAS 从基线到 4 周诱导期结束（终点）测量患者报告的健康状况变化。EQ-5D-5L 的每个域包括 5 个感知问题级别（L1：没有问题；L5：极端问题）。结果：全分析集包括 223 名患者（ESK+AD：114；AD+PBO：109）。在终点，ESK+AD 组健康状况指数的平均 (SD) 变化为 0.288 (0.2317)，AD+PBO 组为 0.231 (0.2506)，得分越高反映功能水平越高。在终点，ESK+AD 与 AD+PBO 组中报告问题的患者百分比（每个维度的 L2-L5 响应分组）：活动性（13.5% 对 25.7%）、自我护理（16.2% 对 30.5%）、日常活动（55.0% 对 71.4%）、疼痛（38.7% 对 52.4%）和焦虑/抑郁（71.2% 对 78.1%）。ESK+AD 的 EQ-VAS 评分的平均 (SD) 变化为 29.1 (26.32)，AD+PBO 组为 20.9 (26.60)。结论：