Caplyta in Borderline Personality Disorder

Launched by UNIVERSITY OF CHICAGO · Apr 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the medication Caplyta (lumateperone) to see if it can help adults with borderline personality disorder (BPD). The trial will involve 60 participants who will be randomly assigned to receive either Caplyta or a placebo (which looks like the medication but has no active ingredients) for 8 weeks. The goal is to find out if those taking Caplyta experience a greater reduction in their BPD symptoms compared to those taking the placebo.

To be eligible for this trial, participants must be between 18 and 65 years old, have a primary diagnosis of BPD, and have been receiving weekly cognitive behavioral therapy for at least the past two months. They also need to be able to understand and sign a consent form. During the trial, participants will have regular check-ins to monitor their progress and any side effects. It's important to know that certain conditions, like unstable medical illnesses or a history of specific mental health disorders, could exclude someone from participating. This trial is currently recruiting participants, and it offers a potential opportunity for those struggling with BPD to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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