A Study to Test Different Doses of BI 1569912 in People With Depression
NCT ID: NCT06558344
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2024-10-01
2025-05-12
Brief Summary
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Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.
Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 1569912 (low dose)
BI 1569912
BI 1569912
BI 1569912 (medium dose)
BI 1569912
BI 1569912
BI 1569912 (high dose)
BI 1569912
BI 1569912
Placebo matching BI 1569912
Placebo matching BI 1569912
Placebo matching BI 1569912
Interventions
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BI 1569912
BI 1569912
Placebo matching BI 1569912
Placebo matching BI 1569912
Eligibility Criteria
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Inclusion Criteria
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Women of childbearing potential (WOCBP) must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly plus one additional barrier method. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
* Established diagnosis of Major depressive disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI) with a duration of the current depressive episode ≥8 weeks AND ≤24 months at the time of randomisation
* Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score ≥20
* Clinical Global Impression- Severity Scale (CGI-S) score ≥4
Exclusion Criteria
* Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator
* Diagnosis of any other mental disorder that was the primary focus of treatment within 6 months prior to screening (as per clinical discretion of the investigator)
* 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)
* History or presence (upon clinical examination) of seizure disorders or an increased risk of seizures (first degree relative with epilepsy), stroke, brain tumour, or any other major neurological illness that could impact participation in the trial
* A current or recent history of clinically significant suicidal ideation with intent within the past 3 months, corresponding to a score of 4 or 5 for ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) or a suicidal attempt within the past year, as indicated by the C-SSRS at screening visit
* Participants with a body mass index (weight \[kg\]/height \[m\]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Clinical Innovations, Inc
Bellflower, California, United States
ASCLEPES Research Centers, P.C. dba Alliance Research
Long Beach, California, United States
Excell Research Inc.
Oceanside, California, United States
CiTrials-Riverside-63180
Riverside, California, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Lumos Clinical Research
San Jose, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
Research Centers of America-Hollywood-67537
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc-Jacksonville-62642
Jacksonville, Florida, United States
CCM Clinical Research Group, LLC-Miami-68482
Miami, Florida, United States
Optimus U Corporation-Miami-69452
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc-Orlando-62685
Orlando, Florida, United States
Advanced Discovery Research LLC
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Psych Atlanta, PC
Marietta, Georgia, United States
Pharmasite Research, Incorporated
Baltimore, Maryland, United States
Copley Clinical
Boston, Massachusetts, United States
Boston Clinical Trials
Roslindale, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
ActivMed
Portsmouth, New Hampshire, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Berman Clinical
New York, New York, United States
Davis Clinical
The Bronx, New York, United States
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, United States
Surburban Research Associates, Inc.
Media, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc-Memphis-65988
Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Core Clinical Research
Everett, Washington, United States
Uematsu Mental Clinic
Fukuoka, Chikugo, , Japan
Kaku Mental Clinic
Fukuoka, Fukuoka, , Japan
Hirota Clinic
Fukuoka, Kurume, , Japan
Yutaka Clinic
Kanagawa,Sagamihara, , Japan
Maynds Tower Mental Clinic
Tokyo, Shibuya-ku, , Japan
Ichigaya Himorogi Clinic
Tokyo, Shinjuku-ku, , Japan
Countries
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Related Links
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Related Info
Other Identifiers
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1447-0012
Identifier Type: -
Identifier Source: org_study_id
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