Randomized, double-blind, placebo-controlled Phase II parallel study (n=70) comparing IV MIJ821 (0.16 and 0.32 mg/kg; weekly or bi-weekly) versus placebo and an active ketamine comparator in 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.
MIJ821 low dose 0.16 mg/kg given by infusion weekly
MIJ821 infusion (low dose) 0.16 mg/kg
MIJ821 low dose 0.16 mg/kg given by infusion bi-weekly
MIJ821 infusion (low dose) 0.16 mg/kg
MIJ821 high dose 0.32 mg/kg given by infusion weekly
MIJ821 infusion (high dose) 0.32 mg/kg
MIJ821 high dose 0.32 mg/kg given by infusion bi-weekly
MIJ821 infusion (high dose) 0.32 mg/kg
Placebo infusion weekly
Placebo infusion weekly
Ketamine infusion 0.5 mg/kg weekly (active comparator)
Ketamine 0.5 mg/kg weekly; dose capped at 40 mg/day for patients >80 kg