Caplyta in Borderline Personality Disorder

NCT05356013 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB21-0974
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)

  A clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms.

  8 weeks

Secondary Outcomes (10)

• Modified Overt Aggression Scale

  8 Weeks

• Young Mania Rating Scale

  8 Weeks

• Self-Report Version of Zanarini Scale

  8 Weeks

• Borderline Evaluation of Severity Over Time

  8 Weeks

• Barratt Impulsiveness Scale (BIS)

  8 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

All subjects who are randomized to Placebo will receive an identical placebo pill to the experimental drug starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. After study conclusion (week 8), the dose will be discontinued.

Drug: Placebo

Caplyta

EXPERIMENTAL

All subjects who are randomized to Caplyta will receive 42mg/day starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. Dosage changes and reductions will not be permitted. After study conclusion (week 8), the dose will be discontinued.

Drug: Caplyta

Interventions

Caplyta DRUG

Atypical antipsychotic

Also known as: lumateperone

Caplyta

Placebo DRUG

Pill that contains no medicine.

Also known as: no other names

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Intra-Cellular Therapies, Inc.: collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jon E. Grant
• Organization: University of Chicago

jgrant4@bsd.uchicago.edu

7738341325

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: May 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Locations

US (1)