A study to test different doses of BI 1358894 and find out whether they reduce symptoms in people with borderline personality disorder

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 355

Inclusion Criteria

- Patients meeting diagnostic criteria of BoPD per DSM-5 at screening visit, confirmed by SCID-5-PD.
- 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)1 able and willing to use two methods of contraception, 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.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 (in addition to those described in Exclusion 1 and 2) 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 (e.g. DBT, cognitive behavior therapy (CBT), Interpersonal therapy) for BoPD within the last 3 months prior to screening. Patients with ongoing, stable psychotherapy >3 months prior to Screening (and intend to maintain the same frequency during the study) may qualify as per clinical judgement of the investigator.
- Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study (unless allowed per protocol, see Section 4.2.2.1). Investigators may use their clinical discretion to wash out (at least 3 half-lives of referenced medication) psychotropic medications during screening period. Such wash-out of ongoing psychotropic medication must complete at least 7 days prior to randomization.
- Further criteria apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objectives are to demonstrate a non-flat curve, evaluate the dose-response<br>relationship and assess the treatment effect size.<br>;Secondary Objective: Not applicable;Primary end point(s): 1) Change from baseline in ZAN-BPD total score;Timepoint(s) of evaluation of this end point: 1) week 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Response defined as =30% ZAN-BPD reduction from baseline<br>2) Change from baseline in (DERS-16) total score<br>3) Change from baseline in STAI-S total score<br>4) Change from baseline in PHQ-9 total score<br>5) Change from baseline in CGI-S<br>6) Change from baseline in PGI-S;Timepoint(s) of evaluation of this end point: 1) week 10<br>2) week 10<br>3) week 10<br>4) week 10<br>5) week 10<br>6) week 10<br>

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