Two early-phase trials characterize an oral prolonged-release racemic ketamine tablet (KET01) that minimizes dissociation but fails to separate from placebo on depression severity at day 21.
Ketamine is known for rapid antidepressant effects but has significant dissociative and cardiovascular side effects, necessitating safer alternatives. Oral KET01 showed minimal dissociation and cardiovascular effects but did not meet the primary efficacy endpoint compared to placebo. While preliminary efficacy was observed within the first week, further research on KET01's long-term antidepressant effects and safety is necessary. Oral KET01 may offer a safer at-home treatment option for depression, pending more research.
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Authors:Walter M, Zu Eulenburg C, Damyanova A, Schmid K, Schwienbacher I, Papanastasiou E, Maiboe K, Arvastson L, Strote C, Gehrlach D, Eriksson H
Citation:Walter M, Zu Eulenburg C, Damyanova A, et al. Oral Prolonged-Release Ketamine for Treatment-Resistant Depression: Two Randomized Clinical Trials. JAMA network open. 2026;9(6):e2619121. doi:10.1001/jamanetworkopen.2026.19121
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