Poster
44
(#44) Long-Term Safety and Efficacy of Esketamine Nasal Spray Maintenance Dosing After a Lapse in Treatment: A Post Hoc Analysis of the SUSTAIN-3 Study
Psych Congress 2025
Abstract: Objective: This post hoc analysis of SUSTAIN-3 (NCT02782104), an open-label long-term extension study of flexibly dosed esketamine nasal spray (ESK) plus ongoing oral antidepressant (OAD) treatment in adults with treatment-resistant depression, evaluated safety and efficacy of continuing maintenance ESK after a >28-day lapse in ESK treatment.
Methods: This analysis included participants who entered the optimization/maintenance (OP/M) phase of SUSTAIN-3 from 1 of 5 parent studies after a >28-day lapse and then continued treatment with ESK maintenance dosing plus ongoing OAD. Changes from original induction (IND) baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9) scores and response rates (≥50% improvement from IND baseline) were assessed. Treatment-emergent adverse events (TEAEs) were monitored throughout.
Results: Of 1148 participants, 84 enrolled directly into OP/M after a >28-day lapse and continued maintenance ESK dosing (mean [SD] lapse, 163.5 [135.2] days). Mean (SD) MADRS and PHQ-9 total scores were 3.1 (6.79) and 3.1 (5.04) points higher at OP/M baseline compared with the end of the parent study. Mean (SD) MADRS and PHQ-9 total scores rapidly improved and remained stable throughout OP/M, improving from IND baseline by −24.1 (10.8; P 0.001) and −11.5 (7.3; P 0.001). Response rates for MADRS and PHQ-9 were 72.6% and 59.5%, respectively, at OP/M last visit. Most common TEAEs were dizziness, nausea, and headache.
Conclusion: This post hoc analysis demonstrates that participants who continued maintenance ESK dosing plus OAD after a >28-day lapse in ESK treatment continued to have significant improvements in depressive symptoms. No new safety signals were identified.
Short Description: In this post hoc analysis of SUSTAIN-3 (NCT02782104), an open-label long-term extension study of flexibly dosed esketamine nasal spray (ESK) in adults with treatment-resistant depression, continuation of ESK at a maintenance dosing schedule after a >28-day lapse in treatment was associated with improvements in depressive symptoms. No new safety signals were identified. These results may provide clinicians with information regarding lapses in ESK treatment or missed doses of ESK.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
Methods: This analysis included participants who entered the optimization/maintenance (OP/M) phase of SUSTAIN-3 from 1 of 5 parent studies after a >28-day lapse and then continued treatment with ESK maintenance dosing plus ongoing OAD. Changes from original induction (IND) baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9) scores and response rates (≥50% improvement from IND baseline) were assessed. Treatment-emergent adverse events (TEAEs) were monitored throughout.
Results: Of 1148 participants, 84 enrolled directly into OP/M after a >28-day lapse and continued maintenance ESK dosing (mean [SD] lapse, 163.5 [135.2] days). Mean (SD) MADRS and PHQ-9 total scores were 3.1 (6.79) and 3.1 (5.04) points higher at OP/M baseline compared with the end of the parent study. Mean (SD) MADRS and PHQ-9 total scores rapidly improved and remained stable throughout OP/M, improving from IND baseline by −24.1 (10.8; P 0.001) and −11.5 (7.3; P 0.001). Response rates for MADRS and PHQ-9 were 72.6% and 59.5%, respectively, at OP/M last visit. Most common TEAEs were dizziness, nausea, and headache.
Conclusion: This post hoc analysis demonstrates that participants who continued maintenance ESK dosing plus OAD after a >28-day lapse in ESK treatment continued to have significant improvements in depressive symptoms. No new safety signals were identified.
Short Description: In this post hoc analysis of SUSTAIN-3 (NCT02782104), an open-label long-term extension study of flexibly dosed esketamine nasal spray (ESK) in adults with treatment-resistant depression, continuation of ESK at a maintenance dosing schedule after a >28-day lapse in treatment was associated with improvements in depressive symptoms. No new safety signals were identified. These results may provide clinicians with information regarding lapses in ESK treatment or missed doses of ESK.
Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company
