Phase 2
N=60
Caplyta in Borderline Personality Disorder
Borderline Personality Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05356013 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2026
Primary outcome: Primary: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) — 8.74; 5.80 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Caplyta (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) |
8.74; 5.80 | — |
| SECONDARY Modified Overt Aggression Scale |
— | — |
| SECONDARY Young Mania Rating Scale |
— | — |
| SECONDARY Self-Report Version of Zanarini Scale |
— | — |
| SECONDARY Borderline Evaluation of Severity Over Time |
— | — |
| SECONDARY Barratt Impulsiveness Scale (BIS) |
— | — |
| SECONDARY Minnesota Impulsive Disorders Interview (MIDI) |
— | — |
| SECONDARY Hamilton Depression Rating Scale |
— | — |
| SECONDARY Hamilton Anxiety Rating Scale |
— | — |
| SECONDARY Quality of Life Inventory |
— | — |
| SECONDARY Sheehan Disability Scale (SDS) |
— | — |
Summary
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. The hypothesis to be tested is that Caplyta will result in greater rates of reduction in symptoms of BPD compared to placebo (improvement in symptoms will be indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
Eligibility Criteria
Inclusion Criteria
- Men and women age 18-65;
- Primary diagnosis of BPD
- Zanarini scale score of at least 9 at baseline
- Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy
- 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 (excluding marijuana given the high rates of marijuana use in BPD and the lack of interaction with Caplyta).
- Use of any new psychotropic medication started within the last 3 months prior to study initiation
- Previous treatment with Caplyta
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Data sourced from ClinicalTrials.gov (NCT05356013). 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.