Phase 2
N=80
Brexpiprazole in Borderline Personality Disorder
Borderline Personality Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03418675 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Mar 2022
Primary outcome: Primary: Zanarini Rating Scale for Borderline Personality Disorder — 14.9; 14.9; 7.6; 6.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rexulti (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Zanarini Rating Scale for Borderline Personality Disorder |
14.9; 14.9; 7.6; 6.7; 4.7; 5.3 | — |
| SECONDARY Modified Overt Aggression Scale (MOAS) |
— | — |
| SECONDARY Young Mania Rating Scale |
— | — |
| SECONDARY Self Report Version of Zanarini Scale |
18.2; 17.6; 12.8; 10.9; 10.7; 7.9 | — |
| SECONDARY Borderline Evaluation of Severity Over Time (BEST) |
40.90; 40.54; 29.15; 23.15 | — |
| SECONDARY Barratt Impulsiveness Scale (BIS) |
76.53; 72.27; 68.13; 70.5 | — |
| SECONDARY Symptom Checklist-90 Revised |
26.17; 25.42; 20.25; 14.21 | — |
| SECONDARY Hamilton Anxiety Rating Scale (HAM-A) |
-2.41; -4.88 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
-2.09; -3.81 | — |
| SECONDARY MINI International Neuropsychiatric Interview |
16; 18; 12; 18; 2; 2 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
17.3; 15.8; 13.3; 10.7; 11.5; 7.8 | — |
| SECONDARY Quality of Life Inventory (QOLI) |
28.89; 28.70; 30.75; 35.71 | — |
| SECONDARY Columbia Suicide Severity Rating Scale (CSSRS) |
1.15; 0.73; 0.23; 0.08 | — |
Summary
The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
Eligibility Criteria
Inclusion Criteria
- Men and women age 18-65;
- Primary diagnosis of BPD
- Zanarini scale score of at least 9 at baseline
- Ability to understand and sign the consent form.
Exclusion Criteria
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Subjects with schizophrenia or bipolar I disorder
- Subjects with an active substance use disorder
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- Illegal substance use based on urine toxicology screening
- Initiation of psychological interventions within 3 months of screening
- Use of any other psychotropic medication
- Previous treatment with Brexpiprazole
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Data sourced from ClinicalTrials.gov (NCT03418675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.