NCT03854578

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

A Single Dose, Randomized, Placebo Controlled Phase I Study on the Effects of BI 1358894 on Functional MRI Measurements in an Emotional Processing Paradigm in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	BI 1358894	Film-coated tablet
DRUG	Placebo matching BI 1358894	Film-coated tablet
DRUG	Citalopram	Film-coated tablet

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-08-27
• Completion: 2019-09-23
• First posted: 2019-02-26
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

1 site across 1 country: Germany