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COMPLETED
NCT05356013
PHASE2

Caplyta in Borderline Personality Disorder

Sponsor: University of Chicago

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-05-10

Completion Date

2025-12-31

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

Caplyta

Atypical antipsychotic

DRUG

Placebo

Pill that contains no medicine.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States