Oral Prolonged-Release Ketamine for Treatment-Resistant Depression

What are the tolerability and antidepressant efficacy of KET01, a prolonged-release tablet formulation of racemic ketamine?In a phase 1 crossover randomized clinical trial (RCT) including 26 healthy volunteers, a single dose of KET01 did not induce dissociative adverse effects, in contrast to the active comparator, intranasal esketamine. In a phase 2 placebo-controlled RCT including 122 outpatients with treatment-resistant depression, daily KET01 reduced depression severity vs placebo at days 4 and 7 but not at day 21 (primary efficacy end point).Although the primary efficacy end point was not met, the antidepressant efficacy signals and tolerability profile of KET01 support its further development for home administration.

Corresponding Author: Hans Eriksson, MD, PhD, HMNC Brain Health, Wilhelm-Wagenfeld-Straße 20, 80807 Munich, Germany (hans.eriksson@hmnc-brainhealth.com).

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