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

A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo matching BI 1569912; Drug: 5 mg BI 1569912; Drug: 10 mg BI 1569912; Drug: 20 mg of BI 1569912

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Chikugo, Japan, 833-0041
    • Uematsu Mental Clinic
  • Fukuoka, Fukuoka, Japan, 810-0022
    • Kaku Mental Clinic
  • Fukuoka, Kurume, Japan, 830-0033
    • Hirota Clinic
  • Kanagawa,Sagamihara, Japan, 252-0303
    • Yutaka Clinic
  • Tokyo, Shibuya-ku, Japan, 151-0053
    • Maynds Tower Mental Clinic
  • Tokyo, Shinjuku-ku, Japan, 162-0843
    • Ichigaya Himorogi Clinic
• United States
  • California
    • Bellflower, California, United States, 90706
      • Clinical Innovations, Inc
    • Long Beach, California, United States, 90807
      • ASCLEPES Research Centers, P.C. dba Alliance Research
    • Oceanside, California, United States, 92056
      • Excell Research Inc.
    • Riverside, California, United States, 92507
      • CiTrials-Riverside-63180
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research, LLC
    • San Jose, California, United States, 95124
      • Lumos Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group LLC
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America-Hollywood-67537
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc-Jacksonville-62642
    • Miami, Florida, United States, 33135
      • Optimus U Corporation-Miami-69452
    • Miami, Florida, United States, 33133
      • CCM Clinical Research Group, LLC-Miami-68482
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc-Orlando-62685
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Advanced Discovery Research LLC
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Marietta, Georgia, United States, 30060
      • Psych Atlanta, Pc
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Incorporated
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Copley Clinical
    • Roslindale, Massachusetts, United States, 02135
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center For Emotional Fitness
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials LLC
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
    • New York, New York, United States, 10029
      • Berman Clinical
    • The Bronx, New York, United States, 10461
      • Davis Clinical
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Sooner Clinical Research, Inc
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Surburban Research Associates, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc-Memphis-65988
  • Texas
    • Dallas, Texas, United States, 75251
      • FutureSearch Trials of Dallas, LP
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg BI 1569912; Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	Drug: 5 mg BI 1569912; Two 2.5 mg tablets of BI 1569912
Experimental: 10 mg BI 1569912; Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablets of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	Drug: 10 mg BI 1569912; One 10 mg tablet of BI 1569912
Experimental: 20 mg BI 1569912; Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.	Drug: 20 mg of BI 1569912; Two 10 mg tablets of BI 1569912
Placebo Comparator: Placebo-matching BI 1569912; Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	Drug: Placebo matching BI 1569912; Placebo matching BI 1569912

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in MADRS Total Score at Week 6	The change from baseline at Week 6 in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score is reported, calculated as [Week 6 MADRS score] - [Baseline MADRS score]. The MADRS score assessed the severity of symptoms in people with depression, consisting of 10 items. Each item was rated from 0 (no symptom) to 6 (severe symptom), with a total score ranging from 0 to 60 (0 = normal/absence of symptoms, 60 = severe depression). The least squares mean and 95% confidence intervals were estimated by a mixed model for repeated measures (MMRM) including the fixed categorical effects of treatment at each time point and the number of antidepressant treatments taken for the current episode (0/1), and the baseline MADRS total score at each time point as fixed continuous effects. The time point is treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.	MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 1447-0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No