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New depression pill shows promise in early trial

NCT ID NCT06280235

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called BI 1569912 in 243 adults aged 18–65 with major depression that didn't improve with previous treatments. Participants took either a low, medium, or high dose of the drug or a placebo once daily for 6 weeks, while continuing their usual depression therapy. Researchers measured changes in depression symptoms using a standard rating scale to see if the drug helps more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1569912
What this could lead to
If it works, this could offer a new add-on option for people with depression that hasn't improved with standard treatments.
What could go wrong
This is an early Phase 2 trial with only 243 participants over 6 weeks, so results may not apply to everyone. The drug may not outperform placebo or could have side effects.

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

243 people

The number who actually took part.

Started

Mar 2024

Finished

Mar 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: 1. Male and female participants, 18 to 65 years of age, both inclusively at the time of consent. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. 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 and in the study protocol. 4. 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 current depressive episode ≥8 weeks at the time of screening visit. 5. Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score \>17. 6. A documented ongoing monotherapy treatment of ≥6 weeks at the randomisation visit, with an selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) specified in the investigator site file (ISF) at adequate dose (at least minimum effective dose as per prescribing information). * The participant must adhere to the screening visit dose of the background SSRI/SNRI until the end of the trial. Participants should be on a stable dose for at least 4 weeks prior to randomisation. * Participants, who, in addition to their monotherapy with an SSRI/SNRI, are taking additional low dose antidepressant medications for purposes other than treating depressive symptoms, are not excluded. The dose must be less than the lowest dose indicated for MDD. 7. In the current episode, participants have shown insufficient treatment response defined by less than 50% response to a maximum of 4 antidepressant treatments of adequate dose and treatment duration (according to Summary of Product Characteristics) as evaluated by the antidepressant treatment response questionnaire (ATRQ). Exclusion criteria: 1. Per MINI, have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder. 2. 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. 3. 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). 4. 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. 5. 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. 6. Participants with a body mass index (weight \[kg\]/height \[m\]²) lower than 18 kg/m² or greater than 40 kg/m² at screening. 7. Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco). 8. Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening or Visit 1A (if applicable). Participants with positive cannabis and benzodiazepine drug tests can be included if the investigator confirms that there is no active substance related disorder. 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

  • A-SHINE s.r.o

    Pilsen, 30100, Czechia

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844, United States

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Aisakura Clinic

    Fukuoka, 810-0001, Japan

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

    Cherven Bryag, 5980, Bulgaria

  • Anima Research Center

    Alken, 3570, Belgium

  • Asclepes Research Centers-Panorama City-62905

    Panorama City, California, 91402, United States

  • Beijing Anding Hospital

    Beijing, 100088, China

  • Boston Clinical Trials

    Roslindale, Massachusetts, 02135, United States

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida, 33133, United States

  • CT Clinical Research

    Cromwell, Connecticut, 06416, United States

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Chicago Research Center, Incorporated

    Chicago, Illinois, 60634, United States

  • Clintrial s.r.o.

    Prague, 100 00, Czechia

  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD

    Sofia, 1408, Bulgaria

  • DCC Mladost-M Varna OOD

    Varna, 9020, Bulgaria

  • Excell Research Inc.

    Oceanside, California, 92056, United States

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • Galiz Research

    Hialeah, Florida, 33016, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Hassman Research Institute-Marlton-66897

    Marlton, New Jersey, 08053, United States

  • Hebei Mental Health Center

    Baoding, 71000, China

  • Hirota Clinic

    Kurume-shi, 830-0033, Japan

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401, United States

  • Iwaki Clinic, Tokushima, Psychosomatic Medicine

    Anan-shi, 774-0014, Japan

  • Kaku Mental Clinic

    Fukuoka, 810-0022, Japan

  • Kuramitsu Hospital

    Fukuoka, 819-0037, Japan

  • Kyorin University Hospital

    Mitaka-shi, 181-8611, Japan

  • MHC - Ruse, EOOD

    Rousse, 7003, Bulgaria

  • Maynds Tower Mental Clinic

    Shibuya-ku, 151-0053, Japan

  • Medical Center "Sv.Naum"

    Sofia, 1113, Bulgaria

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica Ltd.

    Sofia, 1680, Bulgaria

  • Mental Clinic Sakurazaka

    Fukuoka, 810-0023, Japan

  • Midwest Clinical Research

    Dayton, Ohio, 45417, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neuro-Behavioral Clinical Research

    North Canton, Ohio, 44720, United States

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Peking University Sixth Hospital

    Beijing, 100191, China

  • Premier Clinical Research Institute

    Miami, Florida, 33122, United States

  • Rainbow and Sea Hospital

    Karatsu-shi, 847-0031, Japan

  • Shanghai Mental Health Center

    Shanghai, 200030, China

  • Shenzhen Kangning Hospital

    Shenzhen, 518003, China

  • Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH

    Schwerin, 19053, Germany

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112, United States

  • Southwest Biomedical Research, LLC

    Tucson, Arizona, 85712, United States

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 50030, China

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • Tianjin Anding Hospital

    Tianjin, 300222, China

  • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

    Duffel, 2570, Belgium

  • iResearch Atlanta

    Decatur, Georgia, 30030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.