A Study to Test Different Doses of BI 1569912 in People With Depression

Inclusion criteria

• Male and female participants, 18 to 65 years of age, both inclusively at the time ofconsent

• Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial

• Women of childbearing potential (WOCBP) must be ready and able to use a highlyeffective method of birth control per ICH M3 (R2) that results in a low failure rateof less than 1% per year when used consistently and correctly plus one additionalbarrier method. A list of contraception methods meeting these criteria andinstructions on the duration of use is provided in the participant information

• Established diagnosis of Major depressive disorder (MDD), single episode orrecurrent, as confirmed at the time of screening by the Mini-InternationalNeuropsychiatric 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

Exclusion criteria:

• Per Mini International Neuropsychiatric Interview (MINI), have ever met diagnosticcriteria 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 MentalDisorders, Fifth Edition (DSM-5) criteria, at the time of screening visit. Any otherpersonality disorder at screening visit that significantly affects currentpsychiatric status and likely to impact trial participation, as per the judgement ofinvestigator

• Diagnosis of any other mental disorder that was the primary focus of treatmentwithin 6 months prior to screening (as per clinical discretion of the investigator)

• Treatment failure to 2 or more antidepressants in the current episode, defined asless than 50% response to treatments administered at an adequate dose and durationas evaluated by the Antidepressant treatment response questionnaire (ATRQ)

• History or presence (upon clinical examination) of seizure disorders or an increasedrisk of seizures (first degree relative with epilepsy), stroke, brain tumour, or anyother major neurological illness that could impact participation in the trial

• A current or recent history of clinically significant suicidal ideation with intentwithin the past 3 months, corresponding to a score of 4 or 5 for ideation on theColumbia-Suicide Severity Rating Scale (C-SSRS) or a suicidal attempt within thepast 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 orgreater than 40 kg/m2 at screening

• Diagnosis of a moderate to severe substance related disorder as defined by DSM-5criteria within 6 months prior to screening visit (with exception of caffeine andtobacco) Further exclusion criteria apply.