Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study

ABSTRACT:

Introduction

MIJ821 is a novel N-methyl-D-aspartate (NMDA) receptor antagonist, with a potentially low rate of the psychotomimetic side effects that limit the therapeutic utility of ketamine in treatment-refractory depression (TRD).

Objectives

To assess efficacy and safety of MIJ821.

Methods

Adults with TRD (>2 prior treatment failures; Montgomery-Asberg Depression Rating Scale [MADRS], >24) were eligible and were randomized (n=70) to low versus high doses of MIJ821, with two dosing regimens of weekly or biweekly, versus ketamine versus placebo. The primary outcome was change in MADRS total score at 24 hours and final follow up was at 6 weeks.

Results

At 24 hours, adjusted mean differences (ΔAM) versus placebo were –8.25 (p=0.001), –5.71 (p=0.019) and –5

SUBMITTER: Ghaemi N 

PROVIDER: S-EPMC9471356 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature