A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
NCT ID: NCT06280235
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2024-03-27
2025-03-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 1569912 low dose group
BI 1569912
BI 1569912
BI 1569912 medium dose group
BI 1569912
BI 1569912
BI 1569912 high dose group
BI 1569912
BI 1569912
Placebo group
Placebo
Placebo matching BI 1569912
Interventions
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BI 1569912
BI 1569912
Placebo
Placebo matching BI 1569912
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Southwest Biomedical Research, LLC
Tucson, Arizona, United States
Excell Research Inc.
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
Asclepes Research Centers-Panorama City-62905
Panorama City, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
Galiz Research
Hialeah, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
CCM Clinical Research Group, LLC-Miami-68482
Miami, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Chicago Research Center, Incorporated
Chicago, Illinois, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
Boston Clinical Trials
Roslindale, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Midwest Clinical Research
Dayton, Ohio, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Houston Clinical Trials, LLC
Bellaire, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Anima Research Center
Alken, , Belgium
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
Duffel, , Belgium
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, , Bulgaria
MHC - Ruse, EOOD
Rousse, , Bulgaria
Medical Center "Sv.Naum"
Sofia, , Bulgaria
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Medical Center Intermedica Ltd.
Sofia, , Bulgaria
DCC Mladost-M Varna OOD
Varna, , Bulgaria
Hebei Mental Health Center
Baoding, , China
Beijing Anding Hospital
Beijing, , China
Peking University Sixth Hospital
Beijing, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
Shanghai Mental Health Center
Shanghai, , China
Shenzhen Kangning Hospital
Shenzhen, , China
The First Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin Anding Hospital
Tianjin, , China
A-SHINE s.r.o
Pilsen, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH
Schwerin, , Germany
Iwaki Clinic, Tokushima, Psychosomatic Medicine
Anan-shi, , Japan
Aisakura Clinic
Fukuoka, , Japan
Kaku Mental Clinic
Fukuoka, , Japan
Mental Clinic Sakurazaka
Fukuoka, , Japan
Kuramitsu Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Rainbow and Sea Hospital
Karatsu-shi, , Japan
Hirota Clinic
Kurume-shi, , Japan
Kyorin University Hospital
Mitaka-shi, , Japan
Maynds Tower Mental Clinic
Shibuya-ku, , Japan
Countries
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Related Links
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Related Info
Other Identifiers
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1447-0005
Identifier Type: -
Identifier Source: org_study_id
U1111-1297-3126
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-507942-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
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