Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder.

ABSTRACT: Selective N-methyl-D-aspartate receptor subunit 2b negative allosteric modulators (NR2B NAMs) are being explored as potential new treatment options for major depressive disorder (MDD). This Phase Ib, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in adults (N = 59) with moderate-to-severe MDD and insufficient response to ongoing antidepressant monotherapy. Participants were randomized (1:1:1) to a novel NR2B NAM, BI 1569912 (5 mg or 20 mg tablet) or placebo. The primary safety endpoint was the number and percentage of participants with drug-related adverse events (AEs) from the start of treatment to Day 15. Dissociation and psychedelic symptoms were assessed by the Clinician-Administered Dissociative States Scale (CADSS) and Bowdle-Visual Analog Scale (B-V

SUBMITTER: McIntyre RS 

PROVIDER: S-EPMC12598133 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature