Abstract：
OBJECTIVE: To assess the likelihood of attaining response/remission of depressive symptoms with esketamine nasal spray (ESK) plus standard of care (SoC) vs placebo nasal spray (PBO) plus SoC at 4 weeks in patients with major depressive disorder and active suicidal ideation with intent (MDSI) without early response.
METHODS: A post hoc analysis of pooled data from ASPIRE I and ASPIRE II evaluated ESK plus SoC vs PBO plus SoC in adults with MDSI without response (≥50% improvement from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] score) at 24 hours after the first dose or at week 1 after the first two doses (ie, 24-hour and week 1 nonresponders). Response and remission (MADRS score ≤ 12) rates were assessed on day 25.
RESULTS: The analysis included 362 patients (n = 182, ESK plus SoC; n = 180, PBO plus SoC). Among 24-hour nonresponders, more patients receiving ESK plus SoC vs PBO plus SoC achieved response (63.9% vs 48.0%, P = .010) and remission (35.1% vs 24.4%, P = .074) at day 25. Odds of response/remission were higher with ESK plus SoC vs PBO plus SoC (response: 1.89, 95% CI, 1.17-3.05; remission: 1.48, 95% CI, 0.93-2.35). Similar findings were observed among week 1 nonresponders for response (48.4% vs 34.5%, P = .075), remission (25.0% vs 13.1%, P = .060), and odds of response/remission (response: 2.03, 95% CI, 1.22-3.40; remission: 1.63, 95% CI, 1.01-2.62).
CONCLUSIONS: Patients with MDSI not responding within the first week of treatment with ESK plus SoC may still benefit from a full 4-week treatment course.
METHODS: A post hoc analysis of pooled data from ASPIRE I and ASPIRE II evaluated ESK plus SoC vs PBO plus SoC in adults with MDSI without response (≥50% improvement from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] score) at 24 hours after the first dose or at week 1 after the first two doses (ie, 24-hour and week 1 nonresponders). Response and remission (MADRS score ≤ 12) rates were assessed on day 25.
RESULTS: The analysis included 362 patients (n = 182, ESK plus SoC; n = 180, PBO plus SoC). Among 24-hour nonresponders, more patients receiving ESK plus SoC vs PBO plus SoC achieved response (63.9% vs 48.0%, P = .010) and remission (35.1% vs 24.4%, P = .074) at day 25. Odds of response/remission were higher with ESK plus SoC vs PBO plus SoC (response: 1.89, 95% CI, 1.17-3.05; remission: 1.48, 95% CI, 0.93-2.35). Similar findings were observed among week 1 nonresponders for response (48.4% vs 34.5%, P = .075), remission (25.0% vs 13.1%, P = .060), and odds of response/remission (response: 2.03, 95% CI, 1.22-3.40; remission: 1.63, 95% CI, 1.01-2.62).
CONCLUSIONS: Patients with MDSI not responding within the first week of treatment with ESK plus SoC may still benefit from a full 4-week treatment course.
摘要：
目的：评估在没有早期反应的重度抑郁症患者中，使用esketamine鼻喷雾剂（ESK）加标准护理（SoC）与安慰剂鼻喷雾剂（PBO）加SoC在4周时达到缓解/缓解抑郁症状的可能性。
方法：对ASPIREI和ASPIREII的汇总数据进行事后分析，评估了无反应的MDSI成人的ESK加SoC与PBO加SoC（蒙哥马利-奥斯贝格抑郁量表[MADRS]评分比基线改善≥50％）在第一次给药后24小时或前两次给药后第1周（即，24小时和第1周无应答者)。在第25天评估反应和缓解率（MADRS评分≤12）。
结果：分析包括362名患者（n=182，ESK加SoC；n=180，PBO加SoC）。在24小时无应答者中，更多接受ESK加SoC与PBO加SoC的患者获得了缓解(63.9%对48.0%，P=.010）和缓解（35.1%vs24.4%，P=0.074）在第25天。ESK加SoC与PBO加SoC相比，响应/缓解的几率更高（响应：1.89，95％CI，1.17-3.05；缓解：1.48，95％CI，0.93-2.35）。在第1周无反应者中观察到类似的发现（48.4％vs34.5％，P=.075)，缓解(25.0%vs13.1%，P=.060)，和应答/缓解的几率(应答:2.03,95%CI,1.22-3.40;缓解:1.63,95%CI,1.01-2.62)。
结论：在ESK加SoC治疗的第一周内没有反应的MDSI患者仍可从完整的4周疗程中受益。
方法：对ASPIREI和ASPIREII的汇总数据进行事后分析，评估了无反应的MDSI成人的ESK加SoC与PBO加SoC（蒙哥马利-奥斯贝格抑郁量表[MADRS]评分比基线改善≥50％）在第一次给药后24小时或前两次给药后第1周（即，24小时和第1周无应答者)。在第25天评估反应和缓解率（MADRS评分≤12）。
结果：分析包括362名患者（n=182，ESK加SoC；n=180，PBO加SoC）。在24小时无应答者中，更多接受ESK加SoC与PBO加SoC的患者获得了缓解(63.9%对48.0%，P=.010）和缓解（35.1%vs24.4%，P=0.074）在第25天。ESK加SoC与PBO加SoC相比，响应/缓解的几率更高（响应：1.89，95％CI，1.17-3.05；缓解：1.48，95％CI，0.93-2.35）。在第1周无反应者中观察到类似的发现（48.4％vs34.5％，P=.075)，缓解(25.0%vs13.1%，P=.060)，和应答/缓解的几率(应答:2.03,95%CI,1.22-3.40;缓解:1.63,95%CI,1.01-2.62)。
结论：在ESK加SoC治疗的第一周内没有反应的MDSI患者仍可从完整的4周疗程中受益。
