Depressive Disorder, MajorPhase 2NCT06280235
A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
A Phase 2 study testing BI 1569912 in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 52 sites in 7 countries.
Trial 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. 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?
- BI 1569912
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 52 sitesin 7 countries
- Study dates
- 27 Mar 2024to 28 Mar 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 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).
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- 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).
Who cannot join
- 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).
- 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.
Trial locations and contacts
52 sites in 7 countries.
52 sites in 7 countries
United States21 sites
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
Northwest Clinical Research Center
Bellevue, Washington, 98007
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Chicago Research Center, Incorporated
Chicago, Illinois, 60634
CT Clinical Research
Cromwell, Connecticut, 06416
Midwest Clinical Research
Dayton, Ohio, 45417
iResearch Atlanta
Decatur, Georgia, 30030
Galiz Research
Hialeah, Florida, 33016
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, 08053
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Premier Clinical Research Institute
Miami, Florida, 33122
CCM Clinical Research Group, LLC-Miami-68482
Miami, Florida, 33133
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
Excell Research Inc.
Oceanside, California, 92056
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
NRC Research Institute
Orange, California, 92868
Asclepes Research Centers-Panorama City-62905
Panorama City, California, 91402
Boston Clinical Trials
Roslindale, Massachusetts, 02135
Southwest Biomedical Research, LLC
Tucson, Arizona, 85712
Adams Clinical
Watertown, Massachusetts, 02472
Grayline Research Center
Wichita Falls, Texas, 76309
Japan10 sites
Iwaki Clinic, Tokushima, Psychosomatic Medicine
Anan-shi, 774-0014
Aisakura Clinic
Fukuoka, 810-0001
Kaku Mental Clinic
Fukuoka, 810-0022
Mental Clinic Sakurazaka
Fukuoka, 810-0023
Kuramitsu Hospital
Fukuoka, 819-0037
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Rainbow and Sea Hospital
Karatsu-shi, 847-0031
Hirota Clinic
Kurume-shi, 830-0033
Kyorin University Hospital
Mitaka-shi, 181-8611
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
China8 sites
Hebei Mental Health Center
Baoding, 71000
Beijing Anding Hospital
Beijing, 100088
Peking University Sixth Hospital
Beijing, 100191
The Second Xiangya Hospital Of Central South University
Changsha, 410011
Shanghai Mental Health Center
Shanghai, 200030
Shenzhen Kangning Hospital
Shenzhen, 518003
The First Hospital of Hebei Medical University
Shijiazhuang, 50030
Tianjin Anding Hospital
Tianjin, 300222
Bulgaria7 sites
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, 5980
MHC - Ruse, EOOD
Rousse, 7003
Medical Center "Sv.Naum"
Sofia, 1113
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD
Sofia, 1408
Medical Center Hera EOOD
Sofia, 1510
Medical Center Intermedica Ltd.
Sofia, 1680
DCC Mladost-M Varna OOD
Varna, 9020
Belgium2 sites
Anima Research Center
Alken, 3570
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
Duffel, 2570
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH
Schwerin, 19053
About this study
Official title: 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.
Read more
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
- Being tested
- BI 1569912, Placebo
- 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.
BI 1569912Drug
Tablets
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). Receives: 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). Receives: Drug: Placebo |
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
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Mar 2024
- Primary completion26 Feb 2025
- Study completion28 Mar 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 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
- NCT06280235
- Sponsor's protocol ID
- 1447-0005
- Other IDs
- U1111-1297-3126, 2023-507942-10-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2024
- Last updated
- 27 Mar 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.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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06280235
- Acronym / sponsor ID
- 1447-0005
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Posted 27 Mar 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg BI 1569912 | Experimental | Drug: BI 1569912Participants 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). |
| 10 mg BI 1569912 | Experimental | Drug: BI 1569912Participants 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. |
| 20 mg BI 1569912 | Experimental | Drug: BI 1569912Participants administered once daily for six weeks orally two tablets of 10 mg of BI 1569912 (total administered dose of BI 1569912 =20 mg). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants administered once daily for six weeks orally two tablets of placebo matching BI 1569912 (tablet matching in size and weight to BI 1569912 tablets). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| BI 1569912Tablets | Drug | 10 mg BI 1569912, 20 mg BI 1569912, 5 mg BI 1569912 |
| PlaceboTablet | Drug | Placebo |
Primary outcome
Change From Baseline in MADRS Total Score at Week 6
Time frame: 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.
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.
6 secondary outcomes
Change From Baseline in MADRS Total Score at Day 8
Time frame: 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
Time frame: Baseline and at Day 8.
Response Defined as >=50% MADRS Reduction From Baseline at Week 6
Time frame: At baseline and at Week 6.
Remission Defined as MADRS Total Score <=10 at Week 6
Time frame: At Week 6.
Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Day 8
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.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.
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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.
52 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1569912 in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 52 sites in 7 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 9 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Japan, China, Bulgaria, Belgium and 2 more countries. 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 27 Mar 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 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.). 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 27 Mar 2026.