Status:
ACTIVE_NOT_RECRUITING
Caplyta in Borderline Personality Disorder
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Intra-Cellular Therapies, Inc.
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 rando...
Detailed Description
Borderline personality disorder (BPD) is a serious, difficult to treat, psychiatric disorder that causes significant emotional distress, as well as resulting in significant economic burden to health c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05356013
Start Date
May 10 2023
End Date
December 31 2025
Last Update
September 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637