Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression

Summary

This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a weekly or bi-weekly basis. The efficacy was measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration was 6 weeks of treatment plus 1 month of follow up period.

Timeline

Start

2019-02-08

Primary completion

2020-03-23

Completion

2020-03-23

Publications

• Shelton RC, Litman RE, Hassman H, Walling DP, Ros Montalban S, Salva-Coll J, Zajecka J, Sverdlov O, Gomez-Mancilla B, Healy MP, Shanker YG, Berkheimer M, Faller T, von Raison F, Serban C, Cha JH, Ghaemi SN. Rapid Onset and Sustained Efficacy of Onfasprodil (MIJ821), a Novel NR2B Negative Allosteric Modulator, in Patients With Treatment-Resistant Depression: A Phase 2, Randomized, Placebo-Controlled, Proof-of-Concept Study. J Clin Psychiatry. 2025 Aug 6;86(3):23m15246. doi: 10.4088/JCP.23m15246.

Drugs

Indications