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

安慰剂 难治性抑郁症 氯胺酮 加药 医学 不利影响 内科学 拟精神病 随机对照试验 萧条(经济学) 敌手 耐火材料(行星科学) 临床试验 麻醉 重性抑郁障碍 NMDA受体 受体 替代医学 经济 病理 宏观经济学 物理 扁桃形结构 天体生物学
作者
S. Nassir Ghaemi,Alex Sverdlov,Richard C. Shelton,Robert E. Litman
出处
期刊:European Psychiatry [Cambridge University Press]
卷期号:64 (S1): S334-S335 被引量:11
标识
DOI:10.1192/j.eurpsy.2021.897
摘要

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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