A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: BI 1358894; Placebo
Intervention description: Film-coated tablet; Film-coated tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 390.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is open to adults with borderline personality disorder. The purpose of this study
      is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with
      borderline personality disorder. Four different doses of BI 1358894 are tested in the study.

      Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take
      different doses of BI 1358894. Participants in the fifth group take placebo. Participants
      take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894
      tablets but do not contain any medicine.

      Participants are in the study for about 5 months. During this time, they visit the study site
      about 12 times and get about 6 phone calls. At the visits, doctors ask participants about
      their symptoms. The results between the BI 1358894 groups and the placebo group are then
      compared. The doctors also regularly check the general health of the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting diagnostic criteria of borderline personality disorder (BoPD) per
             Diagnostic and Statistical Manual of Mental Disorders(DSM-5) at screening visit,
             confirmed by Structured Interview for DSM-5 Personality Disorder (SCID-5-PD).

          -  Zanarini rating scale for Borderline personality disorder (ZAN-BPD) of ≥ 9 at
             screening (Visit 1) and randomization (Visit 2), with question #2 Affective
             Instability score of ≥2.

          -  Male or female patients, 18-65 years of age at the time of consent

          -  Women of childbearing potential (WOCBP) able and willing to use two methods of
             contraception, as confirmed by the investigator, which include one highly effective
             method of birth control per ICH M3 (R2) that results in a low failure rate of less
             than 1%, plus one barrier method.

             --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following
             menarche and until becoming postmenopausal unless permanently sterile. Permanent
             sterilization methods include hysterectomy, bilateral salpingectomy and bilateral
             oophorectomy. Tubal occlusion/ ligation is NOT a method of permanent sterilization. A
             postmenopausal state is defined as no menses for 12 months without an alternative
             medical cause.

          -  Signed and dated written informed consent in accordance with International Council on
             Harmonization (ICH) - Good Clinical Practice (GCP) and local legislation prior to
             admission to the trial.

          -  further inclusion criteria apply.

        Exclusion Criteria:

          -  Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality
             disorders, as confirmed by SCID-5-PD at screening visit.

          -  Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform
             disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the
             screening visit.

          -  Any other mental disorder that is the primary focus of treatment in the last 6 months
             prior to randomization, as per the clinical judgement of the investigator.

          -  Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to
             randomization.

          -  Initiation or change in any type or frequency of psychotherapy for BoPD within the
             last 3 months prior to screening.

          -  Any ongoing use of psychotropic medications within 7 days prior to randomization or
             during the course of study.

          -  Any suicidal behavior in the past 1 year.

          -  Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale
             (C-SSRS) in the past 3 months.

          -  further exclusion criteria apply.