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New depression pill BI 1569912 put to the test in 225-Person trial

NCT ID NCT06558344

Symptom relief Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new oral medicine, BI 1569912, can help adults aged 18 to 65 with major depressive disorder. 225 participants were randomly assigned to one of three doses of the drug or a placebo, taken daily for 6 weeks. Researchers measured changes in depression symptoms using the MADRS scale and monitored safety. The goal was to find the right dose and see if the drug works better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

225 people

The number who actually took part.

Started

Oct 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Male and female participants, 18 to 65 years of age, both inclusively at the time of consent * 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: * Per Mini International Neuropsychiatric Interview (MINI), have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder * 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 * Diagnosis of a moderate to severe substance related disorder as defined by DSM-5 criteria within 6 months prior to screening visit (with exception of caffeine and tobacco) Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

Contacts and locations

Locations

  • ASCLEPES Research Centers, P.C. dba Alliance Research

    Long Beach, California, 90807, United States

  • ActivMed

    Portsmouth, New Hampshire, 03801, United States

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Advanced Discovery Research LLC

    Atlanta, Georgia, 30318, United States

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103, United States

  • Berman Clinical

    New York, New York, 10029, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • Boston Clinical Trials

    Roslindale, Massachusetts, 02135, United States

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida, 33133, United States

  • California Neuroscience Research

    Sherman Oaks, California, 91403, United States

  • Center For Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • CiTrials-Riverside-63180

    Riverside, California, 92507, United States

  • Clinical Innovations, Inc

    Bellflower, California, 90706, United States

  • Clinical Neuroscience Solutions, Inc-Jacksonville-62642

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc-Memphis-65988

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc-Orlando-62685

    Orlando, Florida, 32801, United States

  • Copley Clinical

    Boston, Massachusetts, 02116, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Davis Clinical

    The Bronx, New York, 10461, United States

  • Excell Research Inc.

    Oceanside, California, 92056, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75251, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Hirota Clinic

    Fukuoka, Kurume, 830-0033, Japan

  • Ichigaya Himorogi Clinic

    Tokyo, Shinjuku-ku, 162-0843, Japan

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229, United States

  • Kaku Mental Clinic

    Fukuoka, Fukuoka, 810-0022, Japan

  • Lumos Clinical Research

    San Jose, California, 95124, United States

  • Maynds Tower Mental Clinic

    Tokyo, Shibuya-ku, 151-0053, Japan

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Optimus U Corporation-Miami-69452

    Miami, Florida, 33135, United States

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786, United States

  • Pharmasite Research, Incorporated

    Baltimore, Maryland, 21208, United States

  • Psych Atlanta, PC

    Marietta, Georgia, 30060, United States

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368, United States

  • Research Centers of America-Hollywood-67537

    Hollywood, Florida, 33024, United States

  • Sooner Clinical Research, Inc

    Oklahoma City, Oklahoma, 73116, United States

  • Surburban Research Associates, Inc.

    Media, Pennsylvania, 19063, United States

  • Uematsu Mental Clinic

    Fukuoka, Chikugo, 833-0041, Japan

  • Yutaka Clinic

    Kanagawa,Sagamihara, 252-0303, Japan

  • iResearch Atlanta

    Decatur, Georgia, 30030, United States

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