A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subject with treatment-resistant depression in the course of Major Depressive Disorder
Multicentre, double-blind, randomised, placebo-controlled Phase II trial (n=88) evaluating inhaled esketamine (three dose levels) versus placebo for treatment-resistant depression; primary endpoint MADRS change at Day 14; includes PK assessments on Day 1 and Day 11.
Details
This multicentre double-blind randomised Phase II study (EudraCT 2018-001963-22) compared three dose levels of inhaled esketamine delivered by dry powder inhaler versus matching placebo in adults (18–65) with treatment-resistant major depressive disorder (n=88).
Primary outcome was change from baseline in MADRS total score at Day 14. Secondary and safety assessments included CGI-S, C-SSRS, CADSS, BPRS, vitals, laboratory measures, withdrawal symptoms (PWC-20), cognition (MoCA) and PK of esketamine and esnorketamine (Day 1 and Day 11).
Subjects were hospitalised around dosing visits per protocol and excluded for significant medical comorbidity, recent substance dependence, or elevated suicidal risk.