ACTIVE_NOT_RECRUITING

Caplyta in Borderline Personality Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder

Quick Facts

Study Start:2023-05-10

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05356013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and women age 18-65; 2. Primary diagnosis of BPD 3. Zanarini scale score of at least 9 at baseline 4. Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy 5. Ability to understand and sign the consent form.	1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination 2. Subjects with schizophrenia or bipolar I disorder 3. Subjects with an active substance use disorder 4. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential 5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) 6. 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). 7. Use of any new psychotropic medication started within the last 3 months prior to study initiation 8. Previous treatment with Caplyta 9. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Inclusion Criteria

Exclusion Criteria

1. Men and women age 18-65;
2. Primary diagnosis of BPD
3. Zanarini scale score of at least 9 at baseline
4. Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy
5. Ability to understand and sign the consent form.

1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
2. Subjects with schizophrenia or bipolar I disorder
3. Subjects with an active substance use disorder
4. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
6. 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).
7. Use of any new psychotropic medication started within the last 3 months prior to study initiation
8. Previous treatment with Caplyta
9. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Contacts and Locations

Principal Investigator

Jon E Grant, MD, JD, MPH

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Jon E Grant, MD, JD, MPH, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-05-10

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Borderline Personality Disorder