A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder

Inclusion Criteria:

• Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding toDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)criteria

• Time since index event according to Life Events Checklist / Clinician-AdministeredPTSD Scale for DSM-5 (CAPS-5) Criterion A at least 3 months before screening visit

• PTSD must be the clinically pre-dominant disorder, as per investigator´s judgement.Other comorbid psychiatric disorders are allowed, unless specifically excluded inthe exclusion criteria

• A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at thescreening visit

• Moderate to severe PTSD confirmed by CAPS-5 range ≥ 30 confirmed at screening visit

• Male or female patients, 18 to 65 years of age, both inclusively at the time ofinformed consent

• Women who are of child-bearing potential (WOCBP) must be able and willing to use twomethods of contraception, as confirmed by the investigator, which include one highlyeffective method of birth control per International Council on Harmonisation (ICH)M3 (R2) that result in a low failure rate of less than 1%, plus one additionalbarrier method

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

Exclusion Criteria:

• Corresponding to DSM-5, had ever met diagnostic criteria for schizophrenia,schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusionaldisorder, brief psychotic disorder or any other psychotic disorder as well as MajorDepressive Disorder (MDD) with psychotic features as assessed by theMini-International Neuropsychiatric Interview (MINI) at the time of screening

• Any psychiatric or non-psychiatric medical condition likely to negatively impacttrial participation as per the judgement of the investigator

• Acute stress disorder or significant traumatic event within 3 months prior to thescreening visit

• Use of stimulant medications within 3 months prior to the screening visit (AttentionDeficit Hyperactivity Disorder (ADHD) diagnosis alone is not exclusionary)

• Severe traumatic brain injury (life-time) or moderate traumatic brain injury withinthe last 2 years prior to screening visit or 3 months for mild traumatic braininjury, based on the Ohio State University Traumatic Brain Injury (TBI)Identification Method Short Form. Or history of traumatic brain injury that wouldimpact ability to complete trial assessments or procedures according toinvestigator.

• Current treatment with trauma focused therapy (i.e. Cognitive Processing Therapy (CPT), Prolonged Exposure Therapy (PE), Eye Movement Desensitization andReprocessing (EMDR)). A psychotherapy in type, intensity and/or frequency other thantrauma focused therapy is allowed if stable within the last 8 weeks prior toscreening and not anticipated to change during the entire course of the trial.Long-term psychotherapy is permitted as long as patients are not in an exposurephase during the trial.

• Diagnosis of a current moderate or severe alcohol use disorder according to MINIwithin 3 months prior to screening visit (mild alcohol use disorder (AUD) andpatients in early remission = criterion not met for between 3 & 12 months areallowed) Further exclusion criteria apply