protocolSection identificationModule nctId: NCT06280235, orgStudyIdInfo id: 1447-0005, secondaryIdInfos id: U1111-1297-3126, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), secondaryIdInfos id: 2023-507942-10-00, type: REGISTRY, domain: CTIS, briefTitle: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-08-12, completionDateStruct date: 2025-10-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: BI 1569912, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8, secondaryOutcomes measure: Change from baseline in MADRS total score at Week 6, secondaryOutcomes measure: Response defined as ≥50% MADRS reduction from baseline at Day 8, secondaryOutcomes measure: Response defined as ≥50% MADRS reduction from baseline at Week 6, secondaryOutcomes measure: Remission defined as MADRS total score ≤10 at Week 6, secondaryOutcomes measure: Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8, secondaryOutcomes measure: Change from baseline in SMDDS total score at Week 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hassman Research Institute, status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 39.89122, lon: -74.92183, locations facility: Neurobehavioral Research, Inc., status: RECRUITING, city: Cedarhurst, state: New York, zip: 11516, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 40.62288, lon: -73.7243, locations facility: Sooner Clinical Research, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Grayline Research Center, status: RECRUITING, city: Wichita Falls, state: Texas, zip: 76309, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 33.91371, lon: -98.49339, hasResults: False