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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
2,494 Previous Clinical Trials
10,916,829 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment still available for participants?

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

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
What site did they apply to?
Research Centers of America
Collaborative Neuroscience Network, LLC (CNS)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Help with depression. I just want to sleep all the time. And I need the funds.
PatientReceived 1 prior treatment
I have trird a few other meds and nothing seems to work and if they do..i dont seem to all that well.
PatientReceived no prior treatments
~16 spots leftby Mar 2025