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

Published online by Cambridge University Press:  13 August 2021

N. Ghaemi ,
A. Sverdlov ,
R. Shelton  and
R. Litman
N. Ghaemi*
Affiliation:
Translational Medicine, Neuroscience, Novartis Institutes for Biomedical Research, Cambridge, United States of America
A. Sverdlov
Affiliation:
Analytics Gdd / Cd&a Gdd, Novartis Pharmaceuticals Corporation, East Hanover, United States of America
R. Shelton
Affiliation:
Department Of Psychiatry And Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, United States of America
R. Litman
Affiliation:
Georgetown University Medical School, CBH Health, LLC, Gaithersburg, United States of America
*
*Corresponding author.

Abstract

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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 –5.67 (p=0.046) and at 48 h were –7.06 (p=0.013), –7.37 (p=0.013), –11.02 (p=0.019) in the pooled MIJ821 low dose, high dose, and ketamine groups, respectively. At 6 weeks, ΔAM (80% CI) versus placebo on MADRS were –6.46 (–11.8, –1.15); p=0.059 for low dose MIJ821, –5.42 (–10.8, –0.02); p=0.099) for high dose MIJ821, and –5.24 (–10.4, –0.06); p=0.097 for ketamine. Further details on dosing, efficacy, and safety outcomes will be provided.

Conclusions

In this proof-of-concept study, MIJ821 was effective and tolerable in TRD. This study was funded by Novartis. Clinical trial.gov: NCT03756129

Conflict of interest

Employee of Novartis.

Keywords

MIJ821depressionefficacysafety
Type
Abstract
Information
European Psychiatry , Volume 64 , Special Issue S1: Abstracts of the 29th European Congress of Psychiatry , April 2021 , pp. S334 - S335
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of the European Psychiatric Association
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