Caplyta in Borderline Personality Disorder

Last updated: March 24, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

2

Condition

Borderline Personality Disorder

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

Placebo

Caplyta

Clinical Study ID

NCT05356013
IRB21-0974
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ofweekly cognitive behavioral therapy

  5. Ability to understand and sign the consent form.

Exclusion

Exclusion Criteria:

  1. Unstable medical illness based on history or clinically significant abnormalities onbaseline 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 childbearingpotential

  5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severityrating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

  6. Illegal substance use based on urine toxicology screening (excluding marijuana giventhe 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 tostudy initiation

  8. Previous treatment with Caplyta

  9. Cognitive impairment that interferes with the capacity to understand andself-administer medication or provide written informed consent

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 10, 2023
Estimated Completion Date:
May 31, 2025

Study 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 care systems. A variety of psychotherapies, particularly dialectical behavior therapy (DBT) and systems training for emotional predictability and problem solving (STEPPS), have shown benefit in reducing many of the core symptoms of BPD. Healthcare systems, however, often lack the funding and appropriate expertise to implement these treatments, and finding trained DBT or STEPPS therapists has been difficult for many people with BPD. While research on the use of medication is ongoing, no drug has yet been approved in the United States or elsewhere for the treatment of BPD. Antidepressants, anti-convulsants, and second generation antipsychotics have all been examined, but current medication options for BPD often provide only partial relief and may have pronounced side effects.

BPD is characterized by a pervasive pattern of severe psychopathological symptoms with instability of affect regulation, impulse control, and aggression. Dysfunctions in the serotoninergic, dopaminergic, and glutamatergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder. Caplyta (lumateperone) therefore has distinctive properties that make it a promising option for patients with BPD. Caplyta is a mechanistically novel agent as it simultaneously modulates serotonin, dopamine, and glutamate, the key neurotransmitters implicated in BPD. Specifically, Caplyta acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor pre-synaptic partial agonist and post-synaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. In addition, because of low rates of side effects, Caplyta should be a well-tolerated and in fact desired medication approach to BPD.

The aim of the present study is to examine the efficacy and safety of Caplyta vs. placebo in adults with BPD, as indicated by a score of at least 9 on the Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale"), a scale of illness severity, at the baseline visit.

Connect with a study center

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

    1.47 miles

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