A study to test different doses of BI 1358894 and find out whether they reduce symptoms in people with borderline personality disorder
- Conditions
- Borderline Personality Disorder
- Registration Number
- JPRN-jRCT2080225372
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 355
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method