Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study
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 A...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2021-04-01
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| Series: | European Psychiatry |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S092493382100897X/type/journal_article |
| _version_ | 1797616854986915840 |
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| author | N. Ghaemi A. Sverdlov R. Shelton R. Litman |
| author_facet | N. Ghaemi A. Sverdlov R. Shelton R. Litman |
| author_sort | N. Ghaemi |
| collection | DOAJ |
| description |
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.
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| first_indexed | 2024-03-11T07:47:19Z |
| format | Article |
| id | doaj.art-762925064b344c5ca28fc595ac94f1b9 |
| institution | Directory Open Access Journal |
| issn | 0924-9338 1778-3585 |
| language | English |
| last_indexed | 2024-03-11T07:47:19Z |
| publishDate | 2021-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | European Psychiatry |
| spelling | doaj.art-762925064b344c5ca28fc595ac94f1b92023-11-17T05:07:27ZengCambridge University PressEuropean Psychiatry0924-93381778-35852021-04-0164S334S33510.1192/j.eurpsy.2021.897Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept studyN. Ghaemi0A. Sverdlov1R. Shelton2R. Litman3Translational Medicine, Neuroscience, Novartis Institutes for Biomedical Research, Cambridge, United States of AmericaAnalytics Gdd / Cd&a Gdd, Novartis Pharmaceuticals Corporation, East Hanover, United States of AmericaDepartment Of Psychiatry And Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, United States of AmericaGeorgetown University Medical School, CBH Health, LLC, Gaithersburg, United States of America 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. https://www.cambridge.org/core/product/identifier/S092493382100897X/type/journal_articleMIJ821depressionefficacysafety |
| spellingShingle | N. Ghaemi A. Sverdlov R. Shelton R. Litman Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study European Psychiatry MIJ821 depression efficacy safety |
| title | Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study |
| title_full | Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study |
| title_fullStr | Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study |
| title_full_unstemmed | Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study |
| title_short | Efficacy and safety of mij821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study |
| title_sort | efficacy and safety of mij821 in patients with treatment resistant depression results from a randomized placebo controlled proof of concept study |
| topic | MIJ821 depression efficacy safety |
| url | https://www.cambridge.org/core/product/identifier/S092493382100897X/type/journal_article |
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