Ketamine exerts rapid antidepressant effects. However, currently available ketamine-based treatments are associated with dissociative and cardiovascular adverse effects. To evaluate the antidepressant efficacy and tolerability of KET01, a novel, oral, prolonged-release racemic ketamine tablet formulation. KET01-03 was an active-comparator, double-blind, double-dummy, crossover phase 1...
IntroductionCurrent ketamine-based therapies for treatment-resistant depression (TRD) can induce dissociative symptoms. A novel oral prolonged-release ketamine formulation (KET01) results in a lower and delayed peak concentration of ketamine, and a higher concentration of the metabolites norketamine and hydroxynorketamine than after intravenous administration. KET01 has limited dissociative...