依他佐辛鼻喷剂治疗伴有急性自杀意念或行为但无早期应答证据的重性抑郁障碍患者的疗效：ASPIRE 的事后 pooled 分析。

Treatment response to esketamine nasal spray in patients with major depressive disorder and acute suicidal ideation or behavior without evidence of early response: a pooled post hoc analysis of ASPIRE.

机构信息

Department of Statistics & Decision Sciences, Janssen Research & Development, LLC, Titusville, NJ, USA.

Department of Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.

出版信息

CNS Spectr. 2023 Aug;28(4):482-488. doi: 10.1017/S1092852922000931. Epub 2022 Jul 29.

DOI:10.1017/S1092852922000931

PMID:35904046

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%, = .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).

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。

方法

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。

结果

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。