Poster
46
(#46) Effect of Esketamine Nasal Spray Monotherapy on Emotional Blunting in Adult Patients With Treatment-Resistant Depression: A Post Hoc Analysis
Psych Congress 2025
Abstract: Objective: This post hoc analysis of a phase 4, double-blind, multicenter study (NCT04599855) examined the effect of esketamine nasal spray (ESK) monotherapy on emotional blunting (EB) in adults with treatment-resistant depression. EB in treatment-resistant depression can significantly impair patients' quality of life and social functioning; understanding EB changes during treatment can help optimize therapeutic strategies.
Methods: Patients were randomly assigned to receive twice-weekly ESK 56 mg, ESK 84 mg, or placebo for 4 weeks. EB was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS) composite (items 7+8) and Patient Health Questionnaire-9 (PHQ-9) item 1 scores. Least squares (LS) mean changes from baseline in composite and PHQ-9 item 1 scores and percentage of patients with 1- or 2-point improvement from baseline were assessed up to day 28. Treatment-emergent adverse events (TEAEs) were monitored.
Results: The analysis included 378 patients (placebo, n=197; ESK 56 mg, n=86; ESK 84 mg, n=95). LS mean change in composite score was significantly greater with ESK 56 mg and 84 mg versus placebo at day 28 and day 2 (P 0.05). At day 28, significantly more patients treated with ESK 56 mg and 84 mg attained a 2-point improvement in composite score versus placebo (52.4%, 67.4% vs 36.2%, respectively; P 0.05). A similar trend was observed with PHQ-1 item 1 scores. Most common TEAEs included nausea, dissociation, dizziness, and headache.
Conclusion: ESK monotherapy significantly improved EB versus placebo as early as day 2, with improvement sustained through day 28, as measured by MADRS (items 7+8) and PHQ-9 item 1 scores.
Short Description: This post hoc analysis of a phase 4, double-blind, multicenter study (NCT04599855) examined the effect of esketamine nasal spray (ESK) monotherapy on emotional blunting (EB) in patients with treatment-resistant depression using Montgomery-Åsberg Depression Rating Scale composite (items 7+8) and Patient Health Questionnaire-9 item 1 scores as a proxy. ESK monotherapy significantly improved EB versus placebo as early as day 2, with improvement sustained through day 28. No new safety signals were identified.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
Methods: Patients were randomly assigned to receive twice-weekly ESK 56 mg, ESK 84 mg, or placebo for 4 weeks. EB was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS) composite (items 7+8) and Patient Health Questionnaire-9 (PHQ-9) item 1 scores. Least squares (LS) mean changes from baseline in composite and PHQ-9 item 1 scores and percentage of patients with 1- or 2-point improvement from baseline were assessed up to day 28. Treatment-emergent adverse events (TEAEs) were monitored.
Results: The analysis included 378 patients (placebo, n=197; ESK 56 mg, n=86; ESK 84 mg, n=95). LS mean change in composite score was significantly greater with ESK 56 mg and 84 mg versus placebo at day 28 and day 2 (P 0.05). At day 28, significantly more patients treated with ESK 56 mg and 84 mg attained a 2-point improvement in composite score versus placebo (52.4%, 67.4% vs 36.2%, respectively; P 0.05). A similar trend was observed with PHQ-1 item 1 scores. Most common TEAEs included nausea, dissociation, dizziness, and headache.
Conclusion: ESK monotherapy significantly improved EB versus placebo as early as day 2, with improvement sustained through day 28, as measured by MADRS (items 7+8) and PHQ-9 item 1 scores.
Short Description: This post hoc analysis of a phase 4, double-blind, multicenter study (NCT04599855) examined the effect of esketamine nasal spray (ESK) monotherapy on emotional blunting (EB) in patients with treatment-resistant depression using Montgomery-Åsberg Depression Rating Scale composite (items 7+8) and Patient Health Questionnaire-9 item 1 scores as a proxy. ESK monotherapy significantly improved EB versus placebo as early as day 2, with improvement sustained through day 28. No new safety signals were identified.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
