Department of Statistics & Decision Sciences, Janssen Research & Development, LLC, Titusville, NJ, USA.
Department of Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
CNS Spectr. 2023 Aug;28(4):482-488. doi: 10.1017/S1092852922000931. Epub 2022 Jul 29.
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.
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.
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%, = .010) and remission (35.1% vs 24.4%, = .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%, = .075), remission (25.0% vs 13.1%, = .060), and odds of response/remission (response: 2.03, 95% CI, 1.22-3.40; remission: 1.63, 95% CI, 1.01-2.62).
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.
评估在伴有活性自杀意念且无早期应答的重度抑郁症（MDD）患者中，与安慰剂鼻腔喷雾（PBO）+标准治疗（SoC）相比，使用艾司氯胺酮鼻腔喷雾（ESK）+SoC 在 4 周时达到抑郁症状缓解/应答的可能性。
ASPIRE I 和 ASPIRE II 的事后分析评估了在接受 ESK+SoC 治疗的伴有活性自杀意念且无应答（MADRS 评分较基线至少改善≥50%）的 MDD 成人患者中，与 PBO+SoC 相比，在首次剂量后 24 小时或首次两剂后 1 周（即 24 小时和 1 周无应答者）的应答和缓解（MADRS 评分≤12）率。在第 25 天评估应答和缓解率。
分析纳入 362 例患者（n=182，ESK+SoC；n=180，PBO+SoC）。在 24 小时无应答者中，与 PBO+SoC 相比，更多接受 ESK+SoC 的患者达到应答（63.9% vs 48.0%， =.010）和缓解（35.1% vs 24.4%， =.074）。与 PBO+SoC 相比，ESK+SoC 具有更高的应答/缓解几率（应答：1.89，95%CI，1.17-3.05；缓解：1.48，95%CI，0.93-2.35）。在首次剂量后 1 周无应答者中，应答（48.4% vs 34.5%， =.075）、缓解（25.0% vs 13.1%， =.060）和应答/缓解几率（应答：2.03，95%CI，1.22-3.40；缓解：1.63，95%CI，1.01-2.62）也存在相似的发现。
在 ESK+SoC 治疗 1 周内无应答的伴有活性自杀意念的 MDD 患者可能仍受益于完整的 4 周治疗疗程。
