Caplyta in Borderline Personality Disorder

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Intra-Cellular Therapies, Inc.

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