A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: BI 1358894
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1358894 dose group 1<br> | Drug: BI 1358894<br>* Film-coated tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Film-coated tablet<br>|
| Experimental: BI 1358894 dose group 2<br> | Drug: BI 1358894<br>* Film-coated tablet<br>|
| Experimental: BI 1358894 dose group 3<br> | Drug: BI 1358894<br>* Film-coated tablet<br>|
| Experimental: BI 1358894 dose group 4<br> | Drug: BI 1358894<br>* Film-coated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Zanarini rating scale for Borderline personality disorder (ZAN-BPD) total score at Week 10 | The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview. | Baseline and week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response defined as ≥30% ZAN-BPD reduction from baseline at Week 10. | The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview. | Baseline and week 10 | 
| Change from baseline in Difficulties in Emotion Regulation Scale (DERS-16) total score at Week 10 | The DERS-16 total score ranges from 16 to 80 with higher scores reflecting greater levels of emotional dysregulation. | Baseline and week 10 | 
| Change from baseline in State-Trait Anxiety Inventory (STAI-S) total score at Week 10. | The STAI-S total score ranges from 20 to 80 with higher scores indicating higher anxiety. | Baseline and week 10 | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) total score at Week 10. | The PHQ-9 total score ranges from 0 to 27 with higher scores indicating higher depression severity. | Baseline and week 10 | 
| Change from baseline in Clinical Global Impression Severity scale (CGI-S) at Week 10 | The CGI-S score ranges from 1 to 7 with higher scores indicating worsening of the patient's illness. | Baseline and week 10 | 
| Change from baseline in Patient Global Impression Severity scale (PGI-S) at Week 10. | The PGI-S score ranges from 1 to 5 with higher scores indicating worsening of the patients's symptoms. | Baseline and week 10 |