Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression

Multi-centre, randomized, subject- and investigator-blinded parallel-group study evaluating IV MIJ821 in patients with treatment-resistant major depressive disorder. Treatment period was 36 days with a screening period and follow-up.

Four active MIJ821 arms (low/high dose, weekly or bi-weekly), a placebo infusion arm, and a ketamine 0.5 mg/kg weekly active comparator arm were tested; primary efficacy assessed by MADRS at 24 hours post-dose and over the treatment period.