60 Participants Needed

Caplyta for Borderline Personality Disorder

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EK
MC
SB
LA
Overseen ByLaurie Avila, BA
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 2
Sponsor: University of Chicago
Prior Safety DataThis treatment has passed at least one previous human trial

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, JD, MPH

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

You have been diagnosed with BPD as your main medical condition.
You understand the information provided in the consent form and can sign it.
You are between 18 and 65 years old, regardless of gender.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Caplyta (42mg/day) or placebo for 8 weeks

8 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Caplyta
  • Placebo
Trial Overview The study tests Caplyta (lumateperone) at 42mg/day against a placebo over an 8-week period. The goal is to see if Caplyta can better reduce BPD symptoms compared to the placebo, as measured by established outcome measures.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CaplytaExperimental Treatment1 Intervention
All subjects who are randomized to Caplyta will receive 42mg/day starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. Dosage changes and reductions will not be permitted. After study conclusion (week 8), the dose will be discontinued.
Group II: PlaceboPlacebo Group1 Intervention
All subjects who are randomized to Placebo will receive an identical placebo pill to the experimental drug starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. After study conclusion (week 8), the dose will be discontinued.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Intra-Cellular Therapies, Inc.

Industry Sponsor

Trials
42
Recruited
10,700+

Findings from Research

In a study of 13 adolescents diagnosed with borderline personality disorder, treatment with low dose flupenthixol (3 mg per day) over eight weeks resulted in significant improvements in impulsivity, depression, general psychopathology, and overall functioning.
These results suggest that low dose flupenthixol may be a promising short-term treatment option for adolescents with borderline personality disorder, addressing a gap in effective therapies for this population.
The successful pharmacological treatment of adolescents and young adults with borderline personality disorder: a preliminary open trial of flupenthixol.Kutcher, S., Papatheodorou, G., Reiter, S., et al.[2018]
In a study of 16 female outpatients with borderline personality disorder, tranylcypromine and carbamazepine were found to significantly improve symptoms compared to placebo, with tranylcypromine showing the most consistent patient-reported benefits.
Alprazolam was associated with increased severity of behavioral dyscontrol, highlighting the importance of careful medication selection in treating borderline personality disorder.
Pharmacotherapy of borderline personality disorder. Alprazolam, carbamazepine, trifluoperazine, and tranylcypromine.Cowdry, RW., Gardner, DL.[2022]
A systematic review of 28 trials involving 1742 participants suggests that second-generation antipsychotics, mood stabilizers, and omega-3 fatty acids may have beneficial effects in treating borderline personality disorder (BPD), although most findings are based on single studies and require further validation.
Antidepressants showed limited support for treating BPD, with no significant impact on total BPD severity or core symptoms, indicating that while they may help with co-occurring conditions, they are not effective for the primary symptoms of BPD.
Pharmacological interventions for borderline personality disorder.Stoffers, J., Völlm, BA., Rücker, G., et al.[2022]

References

The successful pharmacological treatment of adolescents and young adults with borderline personality disorder: a preliminary open trial of flupenthixol. [2018]
Pharmacotherapy of borderline personality disorder. Alprazolam, carbamazepine, trifluoperazine, and tranylcypromine. [2022]
Pharmacological interventions for borderline personality disorder. [2022]
Update on pharmacotherapy of borderline personality disorder. [2019]
Efficacy and tolerability of pharmacotherapies for borderline personality disorder. [2021]
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