Borderline Personality Disorder
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients meeting diagnostic criteria of BoPD per DSM-5 at screening visit, confirmed by SCID-5-PD. 2) ZAN-BPD of >= 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of >=2. 3) Male or female patients, 18-65 years of age at the time of consent 4) Women of childbearing potential (WOCBP) able and willing to use two methods of contraception
Exclusion criteria
Exclusion criteria: 1) Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit 2) Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit. 3) 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. 4) Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization. 5) Initiation or change in any type or frequency of psychotherapy for BoPD within the last 3 months prior to randomization. 6) Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study 7) Any suicidal behavior in the past 1 year 8) Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy exploratory Change from baseline in ZAN-BPD total score at Week 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics 1) Response defined as >=30% ZAN-BPD reduction from baseline at Week 10 2) Change from baseline in Difficulties in Emotion Regulation Scale (DERS-16) total score at Week 10 3) Change from baseline in State-Trait Anxiety Inventory (STAI-State) total score at Week 10 4) Change from baseline in Patient Health Questionnaire (PHQ-9) total score at Week 10 5) Change from baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 6) Change from baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | — |
Countries
Europe, Japan, North America, Oceania, South America
Outcome results
None listed