A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subjects with treatment-resistant bipolar depression

Multicentre, double-blind, randomised, placebo-controlled Phase II study comparing multiple-dose inhaled esketamine versus placebo in adults with treatment-resistant bipolar depression; primary outcome is change in MADRS total score at Day 14 versus baseline.

Secondary and exploratory assessments include durability/time-to-relapse, CGI-S, C-SSRS, CADSS, BPRS, safety vitals and labs, withdrawal symptoms, cognitive effects (MoCA), and PK of esketamine and esnorketamine (Day 1 and Day 11).