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BI 1569912 medium dose group for Major Depressive Disorder

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at day 8
Awards & highlights

Study Summary

This trial is looking for adults between 18 and 65 years old who have major depressive disorder and have not responded to previous treatments. The study is testing a medicine called BI 1569912 to

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8
Secondary outcome measures
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
~60

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,703 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 the recruitment for this study inclusive of individuals aged 70 and above?

"Eligible participants for this research must fall within the age bracket of 18 to 65 years. Among the trials available, there are 112 studies focusing on individuals below 18 and 636 studies targeting those above 65 years old."

Answered by AI

Which individuals meet the requirements to participate in this research endeavor?

"This clinical trial aims to enroll 204 individuals diagnosed with major depressive disorder aged between 18 and 65 years. Essential criteria include a confirmed diagnosis of major depressive disorder, assessed through the mini-international neuropsychiatric interview (MINI) at screening, with a current episode lasting ≥8 weeks. Additionally, participants must have an HDRS-17 score >17, be undergoing monotherapy treatment for at least 6 weeks with specified medications like SSRIs or SNRIs at effective doses as per guidelines in the investigator site file (ISF). They should provide written informed consent following ICH-GCP standards and local regulations before entering the"

Answered by AI

What is the total number of individuals participating in this clinical trial?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this study. The trial was initially posted on March 7, 2024, and last modified on April 2, 2024. Enrollment aims to encompass a total of 204 patients across two designated sites."

Answered by AI

Is this medical study currently accepting participants for enrollment?

"Affirmative. The details on clinicaltrials.gov imply that this trial is currently in search of participants. Initially shared on March 7th, 2024, the information was last revised on April 2nd, 2024. This study aims to recruit a total of 204 patients from two distinct sites."

Answered by AI

Has the medium dosage group of BI 1569912 received approval from the FDA?

"Our research team at Power rates the safety of BI 1569912 in the medium dose group as a 2. This assessment is based on it being a Phase 2 trial, indicating some evidence supporting safety but lacking data on efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Neurobehavioral Research, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
2024. "A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280235.
All > Depression Baltimore > Fort Worth
~136 spots leftby Aug 2025
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