BI 1569912 for Major Depressive Disorder

Phase-Based Progress Estimates
Collaborative Neuroscience Research, Torrance, CAMajor Depressive DisorderBI 1569912 - Drug
18 - 65
All Sexes
What conditions do you have?

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to Day 15

Up to Day 15
Maximum decrease from baseline (peak decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) at any day within a 7 days-interval
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)
Percentage of patients with drug-related adverse events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

BI 1569912 treatment group
1 of 2
Placebo group
1 of 2

Experimental Treatment

Non-Treatment Group

66 Total Participants · 2 Treatment Groups

Primary Treatment: BI 1569912 · Has Placebo Group · Phase 1

BI 1569912 treatment group
Experimental Group · 1 Intervention: BI 1569912 · Intervention Types: Drug
Placebo group
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 15

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,398 Previous Clinical Trials
9,800,942 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Is enrollment in this experiment still available for participants?

" provides evidence that this clinical trial is actively enrolling participants; the trial was initiated on July 20th 2021 and lastly updated November 28th 2022." - Anonymous Online Contributor

Unverified Answer

Has BI 1569912 been cleared by the FDA for public use?

"The safety of BI 1569912 is estimated to be a 1 due to the limited information provided by Phase 1 studies, which are unable to provide sufficient evidence for efficacy and safety." - Anonymous Online Contributor

Unverified Answer

How many individuals are contributing to this research endeavor?

"This clinical trial requires 66 individuals who meet the set criteria for inclusion. Enrolment can take place at InSite Clinical Research in Hollywood, Texas and Collaborative Neuroscience Network, LLC (CNS) in DeSoto, California." - Anonymous Online Contributor

Unverified Answer

Might I be eligible to participate in this experiment?

"To be eligible for this medical trial, potential participants must experience psychosis and involutional aging. The age constraints are 18-65 years old. 66 individuals will ultimately be chosen to partake in the study." - Anonymous Online Contributor

Unverified Answer

Are there numerous health care centers conducting this experiment in North America?

"This trial is currently taking place in 6 different sites, two of which are located in Hollywood and DeSoto respectively. Additionally, Garden Grove offers another site while the other 3 centres can be found elsewhere. Participants should select the closest medical centre to reduce travelling times if they choose to join this experiment." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial include elderly individuals in its recruitment?

"Patients aged 18 to 65 are eligible for this trial. For those below the age of consent, there is a current list of 191 trials; conversely, older patients can find 964 suitable studies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.