borderline personality disorder MedDRA version: 21.1 Level: LLT Classification code 10006033 Term: Borderline personality System Organ Class: 100000004873
Conditions
Interventions
Product Name: BI 1358894
Product Code: BI 1358894
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not yet available
Current Sponsor code: BI 1358894
Other descriptive name: BI 1358894
Con
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Response defined as =30% ZAN-BPD reduction from baseline 2) Change from baseline in (DERS-16) total score 3) Change from baseline in STAI-S total score 4) Change from baseline in PHQ-9 total score 5) Change from baseline in CGI-S 6) Change from baseline in PGI-S;Timepoint(s) of evaluation of this end point: 1) week 10 2) week 10 3) week 10 4) week 10 5) week 10 6) week 10 | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Czechia, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Mexico, Poland, Romania, Spain, Sweden, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed