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 ICHGCP
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 relationship and assess the treatment effect size;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

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