Evaluating Caplyta for treating Borderline Personality Disorder
A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
This study is testing if the medication Caplyta can help adults with borderline personality disorder feel better over eight weeks compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05356013 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of Caplyta (lumateperone) in adults diagnosed with borderline personality disorder (BPD). A total of sixty participants will be randomly assigned to receive either Caplyta or a placebo for eight weeks. The effectiveness of Caplyta will be measured by observing reductions in BPD symptoms, as indicated by established outcome measures. The study addresses the need for effective pharmacological treatments for BPD, given the limitations of current therapeutic options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a primary diagnosis of borderline personality disorder who are currently receiving cognitive behavioral therapy.
Not a fit: Patients with schizophrenia, bipolar I disorder, or those at immediate risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new medication option for patients suffering from borderline personality disorder.
How similar studies have performed: While research on pharmacological treatments for BPD is ongoing, no drug has yet been approved for this condition, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jon E Grant, MD, JD, MPH — University of Chicago
- Study coordinator: Sophie Boutouis, BS
- Email: sboutouis@bsd.uchicago.edu
- Phone: 773-702-9066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.