Poster
36
(#36) Efficacy and Safety of Esketamine Nasal Spray as Monotherapy in Adult Patients with Treatment-Resistant Depression for up to 4-Months of Treatment: A Post Hoc Analysis
Psych Congress 2025
Abstract: Objective: To evaluate the efficacy and safety of esketamine nasal spray (ESK) monotherapy in adults with treatment-resistant depression (TRD) from a multicenter study (NCT04599855).
Methods: During double-blind (DB) treatment, patients were randomly assigned to ESK 56mg, ESK 84mg, or placebo (PBO), twice weekly for 4 weeks. Open-label (OL) ESK treatment (12 weeks) consisted of flexible ESK dosing (56 or 84mg) and an oral antidepressant (OAD) if indicated. Assessments were based on Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (change over time, clinically substantial improvement [12-point reduction], response [≥50% reduction], and remission [total score ≤12]) at DB and OL end points. Treatment-emergent adverse events (TEAEs) were monitored throughout.
Results: The analysis included 227 ESK monotherapy patients without add-on OADs (PBO, 121; ESK 56mg, 48; ESK 84mg, 58). At DB end point, mean (SD) changes in MADRS total score from baseline were −7.9 (10.9), −15.3 (12.7), and −16.7 (12.3) for PBO, ESK 56mg, and ESK 84mg, respectively. From DB end point to OL end point, mean (SD) changes were −12.2 (12.9), −22.0 (13.4) and −20.5 (12.4) for PBO/ESK, ESK 56mg/ESK and ESK 84mg/ESK groups, respectively. At OL end point, clinically substantial improvement was attained in 68.9%, 70.8%, and 77.6%; response in 58.0%, 60.4%, and 65.5%; and remission in 41.2%, 47.9%, 39.7% of patients, respectively. Common TEAEs included nausea, dissociation, dizziness, and headache.
Conclusion: ESK monotherapy treatment for up to 4 months in adults with TRD was associated with clinically substantial and sustained improvements in depressive symptoms. No new safety signals were identified.
Short Description: This post hoc analysis examined adults (n=227) with treatment-resistant depression who received esketamine nasal spray (ESK) monotherapy without add-on oral antidepressants in a multicenter study (NCT04599855). Assessments were based on changes in Montgomery-Åsberg Depression Rating Scale total scores after double-blind (4-week, fixed dose) and open-label (12-week, flexible dose) ESK treatment. ESK monotherapy treatment for up to 4 months was associated with clinically substantial and sustained improvements in depressive symptoms. No new safety signals were identified.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
Methods: During double-blind (DB) treatment, patients were randomly assigned to ESK 56mg, ESK 84mg, or placebo (PBO), twice weekly for 4 weeks. Open-label (OL) ESK treatment (12 weeks) consisted of flexible ESK dosing (56 or 84mg) and an oral antidepressant (OAD) if indicated. Assessments were based on Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (change over time, clinically substantial improvement [12-point reduction], response [≥50% reduction], and remission [total score ≤12]) at DB and OL end points. Treatment-emergent adverse events (TEAEs) were monitored throughout.
Results: The analysis included 227 ESK monotherapy patients without add-on OADs (PBO, 121; ESK 56mg, 48; ESK 84mg, 58). At DB end point, mean (SD) changes in MADRS total score from baseline were −7.9 (10.9), −15.3 (12.7), and −16.7 (12.3) for PBO, ESK 56mg, and ESK 84mg, respectively. From DB end point to OL end point, mean (SD) changes were −12.2 (12.9), −22.0 (13.4) and −20.5 (12.4) for PBO/ESK, ESK 56mg/ESK and ESK 84mg/ESK groups, respectively. At OL end point, clinically substantial improvement was attained in 68.9%, 70.8%, and 77.6%; response in 58.0%, 60.4%, and 65.5%; and remission in 41.2%, 47.9%, 39.7% of patients, respectively. Common TEAEs included nausea, dissociation, dizziness, and headache.
Conclusion: ESK monotherapy treatment for up to 4 months in adults with TRD was associated with clinically substantial and sustained improvements in depressive symptoms. No new safety signals were identified.
Short Description: This post hoc analysis examined adults (n=227) with treatment-resistant depression who received esketamine nasal spray (ESK) monotherapy without add-on oral antidepressants in a multicenter study (NCT04599855). Assessments were based on changes in Montgomery-Åsberg Depression Rating Scale total scores after double-blind (4-week, fixed dose) and open-label (12-week, flexible dose) ESK treatment. ESK monotherapy treatment for up to 4 months was associated with clinically substantial and sustained improvements in depressive symptoms. No new safety signals were identified.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
