LAUSR

Objective. To assess the likelihood of attaining response/remission of depressive symptoms withesketamine nasalspray (ESK) plusstandard ofcare (SoC) vsplacebo nasal spray (PBO)plus SoCat 4weeks in patients withmajor depressive disorder and active suicidal ideation withintent (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-hournonresponders, more patients receiving ESK plusSoC vs PBO plusSoC 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. an oral AD was shown to provide a clinically meaningful improvement in depressive symptoms. 13-16 In those who attained response or remission based on Montgomery-Åsberg Depression Rating Scale (MADRS) score, continuation of ESK plus AD resulted in a statistically significant delay in time to relapse compared to those who switched to AD plus placebo nasal spray (PBO). 17 response or remission on day 25 if early response criteria were not met; odds ratios (ORs), 95% CIs, and number needed to treat (NNT) were computed. No adjustments for multiple comparisons were made.