NCT06280235

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine

A Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (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 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy throughout the study. Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 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 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms. The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	BI 1569912	Tablets
DRUG	Placebo	Tablet

Timeline

• Start date: 2024-03-27
• Primary completion: 2025-02-26
• Completion: 2025-03-28
• First posted: 2024-02-28
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

52 sites across 7 countries: United States, Belgium, Bulgaria, China, Czechia, Germany, Japan

Regulatory

• FDA-regulated drug study