A multi-center, randomized, subject and investigator-blinded, placebo-controlled, active comparator, parallel-group proof of concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of MIJ821 in patients with treatment-resistant depression
Phase IIa, multi-centre, randomized, double-blind, placebo- and active-comparator-controlled study (n=66) evaluating single IV infusions of MIJ821 (multiple dose cohorts) versus ketamine and placebo in adults with treatment-resistant depression; primary outcome MADRS at 24 hours.
Details
Randomized, double-blind, parallel-group Phase II study in 66 adults with treatment-resistant depression comparing multiple MIJ821 intravenous dose cohorts against placebo and an active ketamine comparator; single IV infusion with primary efficacy assessment at 24 hours post-infusion.
Key secondary assessments include dissociative effects, mania risk, melancholic and mixed‑mood symptom effects, anxiety, suicidality, and pharmacokinetics; scheduled assessments at 24 hours, 48 hours and 6 weeks.
IMPs: MIJ821 (lyophilisate for solution for infusion; product code MIJ821; concentration 20 mg) administered IV; active comparator KETOLAR (ketamine) IV solution 50 mg/ml; matching placebo IV solution used.