ArticleDrug safety2026
Esketamine Use and Attempted Suicide or Intentional Self-Harm Among Individuals with Treatment-Resistant Depression: A Retrospective Cohort Study.
Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment-resistant depression (TRD) is associated with elevated suicide risk, but real-world evidence on whether esketamine reduces suicide attempts and intentional self-harm remains limited.
objectiveThe aim was to estimate whether current esketamine exposure was associated with a higher or lower risk of recorded nonfatal, medically attended suicide attempt or intentional self-harm among adults with TRD using a large, real-world administrative claims database.
methodsWe conducted a retrospective cohort study using a nationwide, multipayer administrative claims database from January 2015 through June 2025. Among 1,574,657 adults eligible for matching, patients initiating esketamine after TRD were matched to up to three controls using risk-set propensity score matching. A marginal structural model combined a baseline esketamine treatment probability weight accrued from TRD to index with longitudinal inverse probability of treatment weights. Follow-up continued through month 18.
resultsThe final cohort of complete 3:1 matched sets included 23,140 patients, comprising 5785 treated patients and 17,355 controls, who contributed 295,137 patient-months. Current esketamine exposure was not associated with a statistically distinguishable difference in recorded nonfatal, medically attended suicide attempt or intentional self-harm. The hazard ratio (HR) was 1.017, the 95% confidence interval (CI) was 0.670-1.544, and p = 0.938. In the within-treated analysis, the pooled current-exposure HR was 0.718 (95% CI 0.456-1.130; p = 0.152). In the secondary full-cohort analysis, the estimate per additional cumulative exposed calendar month was 1.039 (95% CI 0.999-1.081; p = 0.057) and the carryover joint test was nonsignificant (p = 0.893).
conclusionsCurrent esketamine exposure was not associated with a statistically distinguishable difference in recorded nonfatal, medically attended suicide attempt or intentional self-harm. The CI remained compatible with clinically meaningful benefit and harm.
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Registered trials
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