A Study to Test Different Doses of BI 1569912 in People With Depression

NCT06558344 | Completed Phase 2 FDA Drug

• 1 other identifier: 1447-0012
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 41

Brief Summary

This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. 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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MADRS total score at Week 6

  The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician reported interview guide designed to assess the severity of symptoms in depressive illness and to be sensitive to treatment effects. The MADRS consists of 10 items: 1. reported sadness 2. apparent sadness 3. inner tension 4. reduced sleep 5. reduced appetite 6. concentration difficulties 7. lassitude 8. inability to feel 9. pessimistic thought 10. suicidal thoughts Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression).

  at baseline and at Week 6

Study Arms (4)

BI 1569912 (low dose)

EXPERIMENTAL

Drug: BI 1569912

BI 1569912 (medium dose)

EXPERIMENTAL

Drug: BI 1569912

BI 1569912 (high dose)

EXPERIMENTAL

Drug: BI 1569912

Placebo matching BI 1569912

PLACEBO COMPARATOR

Drug: Placebo matching BI 1569912

Interventions

BI 1569912 DRUG

BI 1569912

BI 1569912 (high dose); BI 1569912 (low dose); BI 1569912 (medium dose)

Placebo matching BI 1569912 DRUG

Placebo matching BI 1569912

Placebo matching BI 1569912

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (41)

Clinical Innovations, Inc

Bellflower, California, 90706, United States

Location

ASCLEPES Research Centers, P.C. dba Alliance Research

Long Beach, California, 90807, United States

Location

Excell Research Inc.

Oceanside, California, 92056, United States

Location

CiTrials-Riverside-63180

Riverside, California, 92507, United States

Location

Artemis Institute for Clinical Research, LLC

San Diego, California, 92103, United States

Location

Lumos Clinical Research

San Jose, California, 95124, United States

Location

California Neuroscience Research

Sherman Oaks, California, 91403, United States

Location

Pacific Clinical Research Management Group LLC

Upland, California, 91786, United States

Location

Research Centers of America-Hollywood-67537

Hollywood, Florida, 33024, United States

Location

Clinical Neuroscience Solutions, Inc-Jacksonville-62642

Jacksonville, Florida, 32256, United States

Location

CCM Clinical Research Group, LLC-Miami-68482

Miami, Florida, 33133, United States

Location

Optimus U Corporation-Miami-69452

Miami, Florida, 33135, United States

Location

Clinical Neuroscience Solutions, Inc-Orlando-62685

Orlando, Florida, 32801, United States

Location

Advanced Discovery Research LLC

Atlanta, Georgia, 30318, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Psych Atlanta, PC

Marietta, Georgia, 30060, United States

Location

Pharmasite Research, Incorporated

Baltimore, Maryland, 21208, United States

Location

Copley Clinical

Boston, Massachusetts, 02116, United States

Location

Boston Clinical Trials

Roslindale, Massachusetts, 02135, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

ActivMed

Portsmouth, New Hampshire, 03801, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Berman Clinical

New York, New York, 10029, United States

Location

Davis Clinical

The Bronx, New York, 10461, United States

Location

Sooner Clinical Research, Inc

Oklahoma City, Oklahoma, 73116, United States

Location

Surburban Research Associates, Inc.

Media, Pennsylvania, 19063, United States

Location

Clinical Neuroscience Solutions, Inc-Memphis-65988

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

Uematsu Mental Clinic

Fukuoka, Chikugo, 833-0041, Japan

Location

Kaku Mental Clinic

Fukuoka, Fukuoka, 810-0022, Japan

Location

Hirota Clinic

Fukuoka, Kurume, 830-0033, Japan

Location

Yutaka Clinic

Kanagawa,Sagamihara, 252-0303, Japan

Location

Maynds Tower Mental Clinic

Tokyo, Shibuya-ku, 151-0053, Japan

Location

Ichigaya Himorogi Clinic

Tokyo, Shinjuku-ku, 162-0843, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: October 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 12, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (6); US (35)