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BI 1569912 for Depression

Verified Trial
Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you between the ages of 18-65 years old?
When were you diagnosed with Major Depressive Disorder?
Must not have
Have you had a history of cancer in the past 5 years?
Have you been diagnosed with Schizophrenia or Bipolar disorder?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at day 8

Summary

This trial tests a new medicine, BI 1569912, for adults with depression who haven't improved with other treatments. Participants take the medicine daily while continuing their usual therapy. The study checks if the new medicine helps reduce depression symptoms.

Who is the study for?
Adults aged 18-65 with major depressive disorder (MDD) who haven't had success with previous depression treatments can join. They must be on a stable dose of certain antidepressants for at least 6 weeks and agree to use effective birth control if applicable. People are excluded if they don't meet these criteria or have other conditions that could interfere.
What is being tested?
The trial tests BI 1569912, a potential new treatment for depression, against a placebo. Participants continue their usual antidepressant therapy and receive either BI 1569912 or placebo once daily for six weeks while their symptoms and overall health are monitored.
What are the potential side effects?
While the specific side effects of BI 1569912 aren't listed here, common side effects in trials like this may include nausea, headache, sleep disturbances, fatigue, changes in appetite or weight, and possible worsening of depressive symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8
Secondary study objectives
Change from baseline in MADRS total score at Week 6
Change from baseline in SMDDS total score at Week 4
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1569912 medium dose groupExperimental Treatment1 Intervention
Group II: BI 1569912 low dose groupExperimental Treatment1 Intervention
Group III: BI 1569912 high dose groupExperimental Treatment1 Intervention
Group IV: Placebo groupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1569912
2021
Completed Phase 1
~160

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,089 Total Patients Enrolled
~96 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
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