Rapid reduction of depressive symptoms with minimal dissociation: results from the KET01-02 and KET01-03 trials with oral prolonged-release (PR) ketamine KET01
European Psychiatry April 1, 2024 C. Zu Eulenburg, E. Papanastasiou, K. Schmid et al.
A novel oral prolonged-release ketamine formulation (KET01) produces a low and delayed peak concentration of ketamine, high hydroxynorketamine levels, and minimal dissociative effects. In a phase 2 trial in outpatients with treatment-resistant depression, 240 mg/day KET01 added to ongoing treatment reduced depressive symptoms within 7 hours, with a statistically significant separation from placebo on day 4 and day 7, though the difference was not significant at day 21. In a separate phase 1 trial in healthy volunteers, the mean maximum dissociative score was 0.7 for KET01 versus 29.6 for intranasal esketamine. The formulation appears to be a safe, take-at-home adjunct treatment with minimal dissociation.