A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine

NCT06280235 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 1447-0005U1111-1297-31262023-507942-10-00
• Study Type: interventional
• Target: 243
• Locations: 7 countries
• Sites: 52

Brief Summary

This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy throughout the study. Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 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 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms. The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in MADRS Total Score at Week 6

  Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-reported interview guide which evaluates core symptoms of depression. It consists of 10 items and each item is rated on a scale from 0 (no abnormality) to 6 (severe). The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression). The Least Squares Mean (95 % confidence interval) were estimated by restricted maximum likelihood-based mixed model for repeated measures (REML-based MMRM) which includes the fixed categorical effects of treatment at each time point, cohort (with/without lead-in phase), and fixed continuous effects of baseline MADRS total score at each time point. The time point is treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.

  MMRM included measurements from baseline and Day 8, Week 4, Week 6 after first drug administration. MMRM estimates of change from baseline to Week 6 in MADRS total score is reported.

Secondary Outcomes (6)

• Change From Baseline in MADRS Total Score at Day 8

  MMRM included measurements from baseline and Day 8, Week 4, Week 6 after first drug administration. MMRM estimates of change from baseline to Day 8 in MADRS total score is reported.

• Response Defined as >=50% MADRS Reduction From Baseline at Day 8

  Baseline and at Day 8.

• Response Defined as >=50% MADRS Reduction From Baseline at Week 6

  At baseline and at Week 6.

• Remission Defined as MADRS Total Score <=10 at Week 6

  At Week 6.

• Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Day 8

  MMRM included measurements from baseline and Day 8 and at Week 4 after first drug administration. MMRM estimates of change from baseline to Day 8 in SMDDS total score is reported.

Study Arms (4)

5 mg BI 1569912

EXPERIMENTAL

Participants administered once daily for six weeks orally two tablets of 2.5 milligram (mg) of BI 1569912 (total administered dose of BI 1569912 =5 mg).

Drug: BI 1569912

10 mg BI 1569912

EXPERIMENTAL

Participants administered once daily orally for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet.

Drug: BI 1569912

20 mg BI 1569912

EXPERIMENTAL

Participants administered once daily for six weeks orally two tablets of 10 mg of BI 1569912 (total administered dose of BI 1569912 =20 mg).

Drug: BI 1569912

Placebo

PLACEBO COMPARATOR

Participants administered once daily for six weeks orally two tablets of placebo matching BI 1569912 (tablet matching in size and weight to BI 1569912 tablets).

Drug: Placebo

Interventions

BI 1569912 DRUG

Tablets

10 mg BI 1569912; 20 mg BI 1569912; 5 mg BI 1569912

Placebo DRUG

Tablet

Placebo

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 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 and in the study protocol.
• 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.
• Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score \>17.
• 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.
• 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).

You may not qualify if:

• Per 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).
• 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 within 6 months prior to screening visit (with exception of caffeine and tobacco).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (52)

Southwest Biomedical Research, LLC

Tucson, Arizona, 85712, United States

Location

Excell Research Inc.

Oceanside, California, 92056, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Asclepes Research Centers-Panorama City-62905

Panorama City, California, 91402, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Premier Clinical Research Institute

Miami, Florida, 33122, United States

Location

CCM Clinical Research Group, LLC-Miami-68482

Miami, Florida, 33133, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Chicago Research Center, Incorporated

Chicago, Illinois, 60634, United States

Location

ActivMed Practices & Research

Methuen, Massachusetts, 01844, United States

Location

Boston Clinical Trials

Roslindale, Massachusetts, 02135, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Hassman Research Institute-Marlton-66897

Marlton, New Jersey, 08053, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Houston Clinical Trials, LLC

Bellaire, Texas, 77401, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Anima Research Center

Alken, 3570, Belgium

Location

Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

Duffel, 2570, Belgium

Location

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

Cherven Bryag, 5980, Bulgaria

Location

MHC - Ruse, EOOD

Rousse, 7003, Bulgaria

Location

Medical Center "Sv.Naum"

Sofia, 1113, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Medical Center Intermedica Ltd.

Sofia, 1680, Bulgaria

Location

DCC Mladost-M Varna OOD

Varna, 9020, Bulgaria

Location

Hebei Mental Health Center

Baoding, 71000, China

Location

Beijing Anding Hospital

Beijing, 100088, China

Location

Peking University Sixth Hospital

Beijing, 100191, China

Location

The Second Xiangya Hospital Of Central South University

Changsha, 410011, China

Location

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Shenzhen Kangning Hospital

Shenzhen, 518003, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, 50030, China

Location

Tianjin Anding Hospital

Tianjin, 300222, China

Location

A-SHINE s.r.o

Pilsen, 30100, Czechia

Location

Clintrial s.r.o.

Prague, 100 00, Czechia

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

Location

Iwaki Clinic, Tokushima, Psychosomatic Medicine

Anan-shi, 774-0014, Japan

Location

Aisakura Clinic

Fukuoka, 810-0001, Japan

Location

Kaku Mental Clinic

Fukuoka, 810-0022, Japan

Location

Mental Clinic Sakurazaka

Fukuoka, 810-0023, Japan

Location

Kuramitsu Hospital

Fukuoka, 819-0037, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Rainbow and Sea Hospital

Karatsu-shi, 847-0031, Japan

Location

Hirota Clinic

Kurume-shi, 830-0033, Japan

Location

Kyorin University Hospital

Mitaka-shi, 181-8611, Japan

Location

Maynds Tower Mental Clinic

Shibuya-ku, 151-0053, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 27, 2024
• Primary Completion: February 26, 2025
• Study Completion: March 28, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

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

BU (7); JP (10); US (21); DE (2); CZ (2); CN (8); BE (2)