Depressive Disorder, MajorPhase 2NCT06558344
A Study to Test Different Doses of BI 1569912 in People With Depression
A Phase 2 study testing 5 mg BI 1569912, 10 mg BI 1569912 and 20 mg of BI 1569912 in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- 5 mg BI 1569912, 10 mg BI 1569912 and 20 mg of BI 1569912
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 1 Oct 2024to 12 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States35 sites
Advanced Discovery Research LLC
Atlanta, Georgia, 30318
Pharmasite Research, Incorporated
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
Clinical Innovations, Inc
Bellflower, California, 90706
Copley Clinical
Boston, Massachusetts, 02116
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75251
iResearch Atlanta
Decatur, Georgia, 30030
Core Clinical Research
Everett, Washington, 98201
Research Centers of America-Hollywood-67537
Hollywood, Florida, 33024
Clinical Neuroscience Solutions, Inc-Jacksonville-62642
Jacksonville, Florida, 32256
ASCLEPES Research Centers, P.C. dba Alliance Research
Long Beach, California, 90807
Psych Atlanta, PC
Marietta, Georgia, 30060
Surburban Research Associates, Inc.
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc-Memphis-65988
Memphis, Tennessee, 38119
CCM Clinical Research Group, LLC-Miami-68482
Miami, Florida, 33133
Optimus U Corporation-Miami-69452
Miami, Florida, 33135
Berman Clinical
New York, New York, 10029
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Excell Research Inc.
Oceanside, California, 92056
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, 73116
Clinical Neuroscience Solutions, Inc-Orlando-62685
Orlando, Florida, 32801
ActivMed
Portsmouth, New Hampshire, 03801
CiTrials-Riverside-63180
Riverside, California, 92507
Boston Clinical Trials
Roslindale, Massachusetts, 02135
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103
Lumos Clinical Research
San Jose, California, 95124
California Neuroscience Research
Sherman Oaks, California, 91403
Davis Clinical
The Bronx, New York, 10461
Bio Behavioral Health
Toms River, New Jersey, 08755
Pacific Clinical Research Management Group LLC
Upland, California, 91786
Adams Clinical
Watertown, Massachusetts, 02472
Grayline Research Center
Wichita Falls, Texas, 76309
Japan6 sites
Uematsu Mental Clinic
Fukuoka, Chikugo, 833-0041
Kaku Mental Clinic
Fukuoka, Fukuoka, 810-0022
Hirota Clinic
Fukuoka, Kurume, 830-0033
Yutaka Clinic
Kanagawa,Sagamihara, 252-0303
Maynds Tower Mental Clinic
Tokyo, Shibuya-ku, 151-0053
Ichigaya Himorogi Clinic
Tokyo, Shinjuku-ku, 162-0843
About this study
Official title: 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- 5 mg BI 1569912, Placebo matching BI 1569912, 10 mg BI 1569912, 20 mg of BI 1569912
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg BI 1569912Drug
Two 2.5 mg tablets of BI 1569912
Placebo matching BI 1569912Drug
Placebo matching BI 1569912
10 mg BI 1569912Drug
One 10 mg tablet of BI 1569912
20 mg of BI 1569912Drug
Two 10 mg tablets of BI 1569912
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BI 1569912 | Experimental | 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. Receives: Drug: 5 mg BI 1569912 |
| 10 mg BI 1569912 | Experimental | 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. Receives: Drug: 10 mg BI 1569912 |
| 20 mg BI 1569912 | Experimental | 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. Receives: Drug: 20 mg of BI 1569912 |
| Placebo-matching BI 1569912 | Placebo comparator | Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily. Receives: Drug: Placebo matching BI 1569912 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Oct 2024
- Primary completion2 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558344
- Sponsor's protocol ID
- 1447-0012
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06558344
- Acronym / sponsor ID
- 1447-0012
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg BI 1569912 | Experimental | Drug: 5 mg BI 1569912Patients 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. |
| 10 mg BI 1569912 | Experimental | Drug: 10 mg BI 1569912Patients 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. |
| 20 mg BI 1569912 | Experimental | Drug: 20 mg of BI 1569912Patients 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. |
| Placebo-matching BI 1569912 | Placebo comparator | Drug: Placebo matching BI 1569912Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg BI 1569912Two 2.5 mg tablets of BI 1569912 | Drug | 5 mg BI 1569912 |
| Placebo matching BI 1569912Placebo matching BI 1569912 | Drug | Placebo-matching BI 1569912 |
| 10 mg BI 1569912One 10 mg tablet of BI 1569912 | Drug | 10 mg BI 1569912 |
| 20 mg of BI 1569912Two 10 mg tablets of BI 1569912 | Drug | 20 mg BI 1569912 |
Primary outcome
Change From Baseline in MADRS Total Score at Week 6
Time frame: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5 mg BI 1569912, 10 mg BI 1569912 and 20 mg of BI 1569912 in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in MADRS Total Score at Week 6 (time frame: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.