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BI 1569912 for Depression

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
Male and female participants, 18 to 65 years of age at the time of consent
Be older than 18 years old
Must not have
Treatment failure to 2 or more antidepressants in the current episode, defined as less than 50% response to treatments administered at an adequate dose and duration as evaluated by the Antidepressant treatment response questionnaire (ATRQ)
Participants with a body mass index (BMI) lower than 18 kg/m² or greater than 40 kg/m² at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at week 6

Summary

This trial is looking for adults aged 18-65 with major depressive disorder to see if a medication called BI 1569912 helps with depression. Participants are divided into 4 groups, with

Who is the study for?
Adults aged 18-65 with major depressive disorder confirmed by MINI, experiencing a current depressive episode lasting ≥8 weeks but ≤24 months. They must have significant depression severity based on HDRS-17 and CGI-S scores, agree to use effective contraception if applicable, and provide informed consent.
What is being tested?
The trial tests the antidepressant BI 1569912 at different doses against a placebo in four randomly assigned groups. Participants take the tablets daily for six weeks while their depression symptoms are monitored over approximately 2.5 months through seven study site visits.
What are the potential side effects?
While specific side effects of BI 1569912 aren't listed here, common antidepressant side effects include nausea, headaches, sleep disturbances, fatigue, dry mouth, blurred vision, dizziness and sexual dysfunction. Regular health checks during the trial will track any unwanted effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've tried 2 or more antidepressants without much improvement.
Select...
My BMI is not below 18 or above 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at week 6 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 MADRS total score at Week 6

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1569912 (medium dose)Experimental Treatment1 Intervention
Group II: BI 1569912 (low dose)Experimental Treatment1 Intervention
Group III: BI 1569912 (high dose)Experimental Treatment1 Intervention
Group IV: Placebo matching BI 1569912Placebo 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
15,769,071 Total Patients Enrolled
~148 spots leftby Oct 2025
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