NCT06558344

A Study to Test Different Doses of BI 1569912 in People With Depression

A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	BI 1569912	BI 1569912
DRUG	Placebo matching BI 1569912	Placebo matching BI 1569912

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-05-02
• Completion: 2025-05-12
• First posted: 2024-08-16
• Last updated: 2025-08-06

Locations

41 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study