Real-world effectiveness and safety of intranasal esketamine for treatment-resistant depression: Data from the enTRD registry.

Abstract

<h4>Background</h4>Real-world data for intranasal esketamine in treatment-resistant depression (TRD) are needed to characterize effectiveness, suicidality, and tolerability in routine care. We evaluated induction phase outcomes in outpatients with TRD treated at the University Hospital Vienna.<h4>Methods</h4>This retrospective single-center registry study included adults with TRD initiating supervised intranasal esketamine. The primary endpoint was the change in clinician-rated depressive symptom severity (MADRS) from the pre-treatment (PV) to the end of induction (EOI) visit. MADRS scores across baseline (BL), PV, and EOI were analyzed using a mixed model for repeated measures. Secondary outcomes included MADRS three-factor change, self-rated depression score trajectories (PHQ-9), response/remission rates, suicidal ideation, and tolerability.<h4>Results</h4>Of 229 screened patients, 176 initiated esketamine and 156 completed induction. MADRS at BL was 31.5 (SD 6.4), PHQ-9 was 18.5 (SD 4.7). In the primary model, adjusted mean MADRS was 30.3 at PV and 17.7 at EOI, yielding a change of -12.5 points (95%CI -14.1 to -11.0; <i>p</i> < 0.001; Hedges' <i>g</i> = 1.8). All MADRS factors improved, with the largest reduction in the affective-anhedonic domain. PHQ-9 decreased steadily across treatments. Remission was 27.2% and response 57.4% at EOI. Suicidal ideation decreased significantly; no suicide or serious self-harm occurred during induction. Adverse events (AEs) were recorded in 34.7%, with AE-related discontinuation in 3.4%.<h4>Conclusions</h4>Esketamine induction was associated with marked improvement in depressive symptoms and suicidality, with acceptable tolerability under supervised administration. Longer-term registry follow-up and controlled comparative studies are needed to further define the benefit-risk profile beyond induction phase.

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