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BI 1569912 for Major Depressive Disorder

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 15
Awards & highlights

Study Summary

This trial is for adults w/ depression who haven't had relief from other treatments. The goal is to see if a new medicine, BI 1569912, is effective & tolerable. People are randomly assigned to take BI 1569912 or a placebo, & doctors monitor their health for 5 weeks.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum decrease from baseline (peak decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) at any day within a 7 days-interval
Percentage of patients with drug-related adverse events (AEs)
Secondary outcome measures
Montgomery-Åsberg Depression Rating Scale Area under the response curve from pre-dose to the last measurement during inpatient stay at 166:30 hours (MADRS AUC0-166:30)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1569912 treatment groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1569912
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,515 Previous Clinical Trials
11,347,229 Total Patients Enrolled
~15 spots leftby Jun 2025
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