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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1297-3126 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) | |
| 2023-507942-10-00 | Registry Identifier | CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1569912 | Drug | Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score at Week 6 | Montgomery-Ã…sberg 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score at Day 8 | Montgomery-Ã…sberg 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. |
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Inclusion criteria:
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).
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Biomedical Research, LLC | Tucson | Arizona | 85712 | United States | ||
| Excell Research Inc. |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
All patients were screened for eligibility prior to participation in the trial, to ensure that they met all inclusion and none of the exclusion criteria. Patients who met all other eligibility criteria but were not on an SSRI/SNRI at Visit 1, had the option to undergo a 6-week open label lead-in phase with SSRI/SNRI. These patients were reassessed at Visit 1A to determine eligibility to be randomized to the trial.
A Phase II dose-finding trial to examine the efficacy and safety of oral BI 1569912 once daily over a 6-week treatment period in adult patients with moderate-to-severe major depressive disorder (MDD) who failed to respond to 1 or more antidepressants of adequate dose and duration in the current episode and who were still on stable treatment with current selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 5 mg BI 1569912 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2024 | Feb 18, 2026 |
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| Placebo | Drug | Tablet |
|
| 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-Ã…sberg 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-Ã…sberg 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-Ã…sberg 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. |
| Oceanside |
| California |
| 92056 |
| United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Asclepes Research Centers-Panorama City-62905 | Panorama City | California | 91402 | United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Premier Clinical Research Institute | Miami | Florida | 33122 | United States |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Chicago Research Center, Incorporated | Chicago | Illinois | 60634 | United States |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | United States |
| Boston Clinical Trials | Roslindale | Massachusetts | 02135 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| Hassman Research Institute-Marlton-66897 | Marlton | New Jersey | 08053 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Midwest Clinical Research | Dayton | Ohio | 45417 | United States |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | United States |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Houston Clinical Trials, LLC | Bellaire | Texas | 77401 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Anima Research Center | Alken | 3570 | Belgium |
| Universitair Psychiatrisch Centrum Duffel (UPC Duffel) | Duffel | 2570 | Belgium |
| Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov | Cherven Bryag | 5980 | Bulgaria |
| MHC - Ruse, EOOD | Rousse | 7003 | Bulgaria |
| Medical Center "Sv.Naum" | Sofia | 1113 | Bulgaria |
| DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD | Sofia | 1408 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| Medical Center Intermedica Ltd. | Sofia | 1680 | Bulgaria |
| DCC Mladost-M Varna OOD | Varna | 9020 | Bulgaria |
| Hebei Mental Health Center | Baoding | 71000 | China |
| Beijing Anding Hospital | Beijing | 100088 | China |
| Peking University Sixth Hospital | Beijing | 100191 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | 410011 | China |
| Shanghai Mental Health Center | Shanghai | 200030 | China |
| Shenzhen Kangning Hospital | Shenzhen | 518003 | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | 50030 | China |
| Tianjin Anding Hospital | Tianjin | 300222 | China |
| A-SHINE s.r.o | Pilsen | 30100 | Czechia |
| Clintrial s.r.o. | Prague | 100 00 | Czechia |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH | Schwerin | 19053 | Germany |
| Iwaki Clinic, Tokushima, Psychosomatic Medicine | Anan-shi | 774-0014 | Japan |
| Aisakura Clinic | Fukuoka | 810-0001 | Japan |
| Kaku Mental Clinic | Fukuoka | 810-0022 | Japan |
| Mental Clinic Sakurazaka | Fukuoka | 810-0023 | Japan |
| Kuramitsu Hospital | Fukuoka | 819-0037 | Japan |
| Fukuoka University Hospital | Fukuoka, Fukuoka | 814-0180 | Japan |
| Rainbow and Sea Hospital | Karatsu-shi | 847-0031 | Japan |
| Hirota Clinic | Kurume-shi | 830-0033 | Japan |
| Kyorin University Hospital | Mitaka-shi | 181-8611 | Japan |
| Maynds Tower Mental Clinic | Shibuya-ku | 151-0053 | Japan |
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).
| FG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. |
| FG003 | 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). |
| COMPLETED |
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| NOT COMPLETED |
|
|
The treated set (TS) includes all participants who were randomized and treated with the investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Montgomery-Åsberg Depression Rating Scale at baseline | 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 total score is the sum of the scores of the 10 items and could range from 0 to 60 (from normal with absence of symptoms to severe depression). | The primary analysis set (PAS) comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary analysis set (PAS) comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. All participants in the PAS are included in the MMRM analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 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. |
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| Secondary | 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. | The primary analysis set (PAS) comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. All participants in the PAS are included in the MMRM analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 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. |
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| Secondary | 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. | Primary analysis set (PAS): The PAS comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. Percentages are based on observed cases. | Posted | Number | percentage of participants | Baseline and at Day 8. |
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| Secondary | 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. | The primary analysis set (PAS) comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. Percentages are based on observed cases. | Posted | Number | percentage of participants | At baseline and at Week 6. |
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| Secondary | 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. | Primary analysis set (PAS): The PAS comprises all randomised participants who received at least one dose of IMP during the trial and had a baseline MADRS total score ≥24. Percentages are based on observed cases. | Posted | Number | percentage of participants | At Week 6. |
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| Secondary | 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. | The treated set (TS) includes all participants who were randomized and treated with the investigational medicinal product (IMP). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 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. |
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| Secondary | 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. | The treated set (TS) includes all participants who were randomized and treated with the investigational medicinal product (IMP). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 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. |
|
"All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events": From first administration of trial drug until last administration of trial drug plus residual effect period (REP=8 days), up to 57 days.
The treated set (TS) includes all participants who were randomized and treated with the investigational medicinal product (IMP).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 79 | 1 | 79 | 14 | 79 |
| EG001 | 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). | 0 | 40 | 0 | 40 | 8 | 40 |
| EG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. | 1 | 41 | 1 | 41 | 3 | 41 |
| EG003 | 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). | 0 | 83 | 1 | 83 | 16 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2025 | Feb 26, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
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MMRM results were used as input for the MCPMod. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 1569912 and placebo was tested using the Multiple Comparison Procedure and Modelling (MCPMod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax1, Emax2, exponential, sigmoid Emax) while keeping full control of the type I error (one-sided alpha of 0.100). | MCPMod sigmoid Emax model fit | Model assumption: 20% of the maximum effect (ED20) is achieved at 5 mg, 80% of the maximum effect (ED80) at 10 mg dose. Fixed hill parameter h=4. | 0.3113 | Adjusted p-value. | Other | MMRM results were used as input for the MCPMod. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 1569912 and placebo was tested using the Multiple Comparison Procedure and Modelling (MCPMod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax1, Emax2, exponential, sigmoid Emax) while keeping full control of the type I error (one-sided alpha of 0.100). | MCPMod linear model fit | Model assumption: Linear dose response. | 0.3611 | Adjusted p-value. | Other | MMRM results were used as input for the MCPMod. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 1569912 and placebo was tested using the Multiple Comparison Procedure and Modelling (MCPMod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax1, Emax2, exponential, sigmoid Emax) while keeping full control of the type I error (one-sided alpha of 0.100). | MCPMod Emax1 model fit | Model assumption: 50% of the maximum effect (ED50) is achieved at the 5 mg dose. | 0.5531 | Adjusted p-value. | Other | MMRM results were used as input for the MCPMod. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 1569912 and placebo was tested using the Multiple Comparison Procedure and Modelling (MCPMod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax1, Emax2, exponential, sigmoid Emax) while keeping full control of the type I error (one-sided alpha of 0.100). | MCPMod Emax2 model fit | Model assumption: 95% of the maximum effect (ED95) is achieved at the 10 mg dose. | 0.8096 | Adjusted p-value. | Other | MMRM results were used as input for the MCPMod. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| Least Squares Mean difference (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. | Mean Difference (Net) | 4.2 | 2-Sided | 95 | 0.3 | 8.1 | Least Squares Mean "5 mg BI 1569912"-Least Squares Mean "Placebo". | Other | No confirmatory hypothesis testing was performed. |
| Least Squares Mean difference (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. | Mean Difference (Net) | 0.1 | 2-Sided | 95 | -3.8 | 4.0 | Least Squares Mean "10 mg BI 1569912"-Least Squares Mean "Placebo". | Other | No confirmatory hypothesis testing was performed. |
| Least Squares Mean difference (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. | Mean Difference (Net) | -0.4 | 2-Sided | 95 | -3.6 | 2.9 | Least Squares Mean "20 mg BI 1569912"-Least Squares Mean "Placebo". | Other | No confirmatory hypothesis testing was performed. |
| 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). |
| OG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. |
| OG003 | 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). |
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Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet.
| OG003 | 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). |
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Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet.
| OG003 | 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). |
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Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet.
| OG003 | 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). |
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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). |
| OG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. |
| OG003 | 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). |
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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).
| OG002 | 10 mg BI 1569912 | Participants administered once daily for six weeks orally one tablet of 10 mg of BI 1569912 (total administered dose of BI 1569912 =10 mg) and one placebo tablet. |
| OG003 | 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). |
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