CompletedPhase 2

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

United States, Japan225 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * Male and female participants, 18 to 65 years of age, both inclusively at the time of consent * Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Women of childbearing potential (WOCBP) must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly plus one additional barrier method. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information * Established diagnosis of Major depressive disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI) with a duration of the current depressive episode ≥8 weeks AND ≤24 months at the time of randomisation * Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score ≥20 * Clinical Global Impression- Severity Scale (CGI-S) score ≥4 Exclusion criteria: * Per Mini International Neuropsychiatric Interview (MINI), have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder * Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features as per Diagnostic and…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested BI 1569912 for major depression and is now completed — has the data been published yet, and does anything in the results suggest this drug might be a good option to discuss for my situation?
2The trial measured improvement in depression symptoms using the MADRS score at 6 weeks — is 6 weeks considered a meaningful timeframe for judging whether a treatment is working, compared to antidepressants I might already be considering?
3Since this is a Phase 2 trial, the main focus was on finding the right dose rather than fully proving safety and effectiveness — what does that mean for how much we actually know about the risks of BI 1569912 at this point?
4The trial tested different doses of BI 1569912 — do you know which dose or doses showed the most promising results, and are there any known side effects I should be aware of from the Phase 2 data?
5Given that this trial has already completed enrollment, are there follow-on Phase 3 trials or other studies of BI 1569912 that might still be open, or would standard depression treatments be a more practical path for me right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in MADRS Total Score at Week 6

Timeframe: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.

Trial details

NCT IDNCT06558344

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-02

Results submitted2026-04-29

View on ClinicalTrials.gov More Depressive Disorder, Major trials