A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions

Summary

To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.

Timeline

Start

2019-03-12

Primary completion

2019-08-27

Completion

2019-09-23

Outcome

Mixed primary results

paper The adjusted treatment differences in the % BOLD signal changes in the faces task showed that BI 1358894 induced signal reduction in bilateral AMY and left AI. PMID 36343427 ↗

registry analysis (other test); Placebo Matching to BI 1358894 vs BI 1358894; p = 0.0105; Mean change -0.08 (90% CI -0.14 to -0.03); ANOVA NCT03854578 ↗

registry analysis (other test); Placebo Matching to BI 1358894 vs BI 1358894; p = 0.3495; Mean change -0.03 (90% CI -0.08 to 0.02); ANOVA NCT03854578 ↗

Publications

• Grimm S, Keicher C, Paret C, Niedtfeld I, Beckmann C, Mennes M, Just S, Sharma V, Fuertig R, Herich L, Mack S, Thamer C, Schultheis C, Weigand A, Schmahl C, Wunder A. The effects of transient receptor potential cation channel inhibition by BI 1358894 on cortico-limbic brain reactivity to negative emotional stimuli in major depressive disorder. Eur Neuropsychopharmacol. 2022 Dec;65:44-51. doi: 10.1016/j.euroneuro.2022.10.009. Epub 2022 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 1358894	Small molecule	100 mg	Oral
Subject	Citalopram	Small molecule	20 mg	Oral

Indications