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

A Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo; Drug: BI 1569912

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Alken, Belgium, 3570
    • Anima Research Center
  • Duffel, Belgium, 2570
    • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
• Bulgaria
  • Cherven Bryag, Bulgaria, 5980
    • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
  • Rousse, Bulgaria, 7003
    • MHC - Ruse, EOOD
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD
  • Sofia, Bulgaria, 1680
    • Medical Center Intermedica Ltd.
  • Sofia, Bulgaria, 1113
    • Medical Center "Sv.Naum"
  • Sofia, Bulgaria, 1408
    • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD
  • Varna, Bulgaria, 9020
    • DCC Mladost-M Varna OOD
• China
  • Baoding, China, 71000
    • Hebei Mental Health Center
  • Beijing, China, 100088
    • Beijing Anding Hospital
  • Beijing, China, 100191
    • Peking University Sixth Hospital
  • Changsha, China, 410011
    • The second Xiangya Hospital of Central South University
  • Shanghai, China, 200030
    • Shanghai Mental Health Center
  • Shenzhen, China, 518003
    • Shenzhen Kangning Hospital
  • Shijiazhuang, China, 50030
    • The First Hospital of Hebei Medical University
  • Tianjin, China, 300222
    • Tianjin Anding Hospital
• Czechia
  • Pilsen, Czechia, 30100
    • A-SHINE s.r.o
  • Prague, Czechia, 100 00
    • CLINTRIAL s.r.o.
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Schwerin, Germany, 19053
    • Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH
• Japan
  • Anan-shi, Japan, 774-0014
    • Iwaki Clinic, Tokushima, Psychosomatic Medicine
  • Fukuoka, Japan, 819-0037
    • Kuramitsu Hospital
  • Fukuoka, Japan, 810-0023
    • Mental Clinic Sakurazaka
  • Fukuoka, Japan, 810-0001
    • Aisakura Clinic
  • Fukuoka, Japan, 810-0022
    • Kaku Mental Clinic
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Karatsu-shi, Japan, 847-0031
    • Rainbow and Sea Hospital
  • Kurume-shi, Japan, 830-0033
    • Hirota Clinic
  • Mitaka-shi, Japan, 181-8611
    • Kyorin University Hospital
  • Shibuya-ku, Japan, 151-0053
    • Maynds Tower Mental Clinic
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Southwest Biomedical Research, LLC
  • California
    • Oceanside, California, United States, 92056
      • Excell Research Inc.
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Panorama City, California, United States, 91402
      • Asclepes Research Centers-Panorama City-62905
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute
    • Miami, Florida, United States, 33133
      • CCM Clinical Research Group, LLC-Miami-68482
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center, Incorporated
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research
    • Roslindale, Massachusetts, United States, 02135
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute-Marlton-66897
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
  • Texas
    • Bellaire, Texas, United States, 77401
      • Houston Clinical Trials, LLC
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg BI 1569912; 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; Tablets
Experimental: 10 mg BI 1569912; 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; Tablets
Experimental: 20 mg BI 1569912; 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; Tablets
Placebo Comparator: Placebo; 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; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in MADRS Total Score at Day 8	Montgomery-Åsberg Depression Rating Scale (MADRS)s 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 intervals) 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 Day 8 in MADRS total score is reported.
Response Defined as >=50% MADRS Reduction From Baseline at Day 8	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). Percentage of participants with a >=50% reduction of the MADRS from baseline at Day 8 is reported. Percentages are rounded to one decimal place.	Baseline and at Day 8.
Response Defined as >=50% MADRS Reduction From Baseline 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). Percentage of participants with a >=50% reduction of the MADRS from baseline at Week 6 is reported. Percentages are rounded to one decimal place.	At baseline and at Week 6.
Remission Defined as MADRS Total Score <=10 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). Percentage of participants with a MADRS total score <=10 at Week 6 is reported. Percentages are rounded to one decimal place.	At Week 6.
Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Day 8	SMDDS is a 16-item patient-reported measure where each item is rated from 0 ("Not at all/Never") to 4 ("Extremely/Always"). Total score ranges from 0-60, with higher scores indicating greater depression severity. Items 11 and 12 are combined by taking the higher score, then summed with the other 14 items. Least Squares Mean (95 % confidence interval) were estimated by restricted maximum likelihood-based mixed model for repeated measures (REML- based MMRM) with fixed categorical effects of treatment at each time point, cohort (with/without lead-in phase) and baseline MADRS total score (</>=24), and fixed continuous effects of baseline SMDDS 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 and at Week 4 after first drug administration. MMRM estimates of change from baseline to Day 8 in SMDDS total score is reported.
Change From Baseline in SMDDS Total Score at Week 4	The SMDDS is a 16-item patient-reported measure where each item is rated from 0 ("Not at all/Never") to 4 ("Extremely/Always"). Total score ranges from 0-60, with higher scores indicating greater depression severity. Items 11 and 12 are combined by taking the higher score, then summed with the other 14 items. Least Squares Mean (95 % confidence interval) were estimated by restricted maximum likelihood-based mixed model for repeated measures (REML- based MMRM) with fixed categorical effects of treatment at each time point, cohort (with/without lead-in phase) and baseline MADRS total score (</>=24), and fixed continuous effects of baseline SMDDS 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 and at Week 4 after first drug administration. MMRM estimates of change from baseline to Week 4 in SMDDS total score 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): March 27, 2024
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 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: 1447-0005; U1111-1297-3126 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP)); 2023-507942-10-00 (Registry Identifier: CTIS)

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.mystudywindow.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