Intranasal esketamine in treatment-resistant depression: long-term dosing patterns and clinical outcomes in a 5-year observational study.

Abstract

<h4>Background</h4>Treatment-resistant depression (TRD) remains a major clinical challenge, and long-term real-world data on intranasal esketamine are limited.<h4>Objectives</h4>To describe long-term dosing patterns and clinical outcomes associated with intranasal esketamine in routine clinical practice.<h4>Design</h4>Single-center observational cohort study with descriptive analyses.<h4>Methods</h4>We analyzed 45 patients with TRD treated with intranasal esketamine in a naturalistic setting, with follow-up extending up to 260 weeks. Esketamine was used adjunctively with ongoing oral antidepressants. Outcomes included the Montgomery-Åsberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Glasgow Antipsychotic Side-effect Scale (GASS). Treatment patterns were summarized using person-time (person-weeks).<h4>Results</h4>Baseline MADRS was 40.0 (SD 4.63). Mean MADRS decreased to 22.9 (SD 7.99) at week 4 and to 9.70 (SD 5.35) at week 52, with mean scores remaining around 9-10 at later time points among patients with available follow-up. Eight patients (17.8%) discontinued treatment (lack of efficacy <i>n</i> = 4; intolerable adverse effects <i>n</i> = 3; lost to follow-up <i>n</i> = 1). No treatment-emergent hypomania or manic symptoms were observed; YMRS scores decreased over time. GASS scores were low overall, with median values of 0 from week 13 onwards.<h4>Conclusion</h4>In a real-world TRD cohort with complex comorbidities, intranasal esketamine used adjunctively was associated with sustained symptom improvement and a favorable long-term safety profile among patients who continued treatment, with dosing evolving from induction to individualized maintenance schedules. Findings are limited by the observational design, concomitant treatments, and survivor bias.<h4>Trial registration</h4>Not applicable.

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