Exploring Esketamine's Therapeutic Outcomes as an FDA-Designated Breakthrough for Treatment-Resistant Depression and Major Depressive Disorder With Suicidal Intent: A Narrative Review.
Cureus February 1, 2024 Suneeta Kumari, Hassan A Chaudhry, Adam Sagot et al. 13 citations
For patients with treatment-resistant depression (TRD) or major depressive disorder with suicidal intent, intranasal esketamine—the S-enantiomer of ketamine—shows greater efficacy as an add-on to standard oral antidepressants than oral antidepressants plus placebo, based on a narrative review of 18 clinical trials. Esketamine received FDA breakthrough designation and approval in 2019-2020. The primary efficacy endpoint in most trials was reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score. The review outlines esketamine's pharmacology, safety profile, adverse effects, and cognitive impact, and compares it favorably to intravenous ketamine as a more practical clinical alternative. Further research is needed on its mechanism of action, a consensus definition of TRD, and use in patients with co-occurring mental illnesses.