Caplyta for Borderline Personality Disorder
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot start any new psychotropic medications within 3 months before the study begins.
How does the drug Caplyta differ from other drugs for borderline personality disorder?
Caplyta is unique because it is an atypical antipsychotic that has been primarily used for treating schizophrenia and bipolar depression, and its use for borderline personality disorder is novel. Unlike other treatments that focus on mood stabilization or antidepressant effects, Caplyta may offer a different mechanism of action by targeting both dopamine and serotonin receptors, which could address a broader range of symptoms in borderline personality disorder.12345
Research Team
Jon E Grant, MD
Principal Investigator
University of Chicago
Eligibility Criteria
This trial is for adults aged 18-65 in the Chicagoland area who have been diagnosed with Borderline Personality Disorder (BPD). Participants must be able to understand and sign a consent form.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Caplyta (42mg/day) or placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Caplyta
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Intra-Cellular Therapies, Inc.
Industry Sponsor