Caplyta for Borderline Personality Disorder

Overseen By Laurie Avila, BA

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: New psychotropics

Disqualifiers: Schizophrenia, Bipolar I, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of Caplyta for treating borderline personality disorder (BPD). Participants will take either Caplyta or a placebo (a pill with no active medicine) over eight weeks to determine if Caplyta reduces BPD symptoms more effectively than the placebo. The trial seeks adults diagnosed with BPD who have participated in weekly cognitive behavioral therapy for at least two months. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

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.

Is there any evidence suggesting that Caplyta is likely to be safe for humans?

Research has shown that Caplyta (lumateperone) is generally safe for use. In studies for other conditions, patients have taken Caplyta without major issues, though some common side effects, such as sleepiness and dry mouth, can occur. These side effects are usually mild. Serious side effects have been rare in these studies. Caplyta is currently undergoing a phase two study for borderline personality disorder (BPD), indicating some safety in earlier research. However, more studies are needed to determine its safety specifically for BPD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for borderline personality disorder?

Most treatments for Borderline Personality Disorder (BPD) focus on therapy and mood stabilizers or antipsychotics like quetiapine or aripiprazole. But Caplyta, the treatment under study, works differently by targeting serotonin and dopamine receptors more precisely. This unique approach could offer a new way to manage BPD symptoms with potentially fewer side effects. Researchers are excited because Caplyta's mechanism might provide relief for patients who haven't responded well to existing medications, offering hope for a more effective and tolerable treatment option.

What evidence suggests that Caplyta might be an effective treatment for borderline personality disorder?

Studies have shown that Caplyta (lumateperone) effectively treats certain mental health conditions, such as schizophrenia, by reducing symptoms like hallucinations and mood swings. In this trial, participants will receive either Caplyta or a placebo to evaluate its effectiveness for borderline personality disorder (BPD). Current research is investigating whether Caplyta can alleviate symptoms like emotional instability and impulsive actions. Early results suggest that Caplyta might improve symptoms more effectively than a placebo. While researchers continue to gather data for BPD, Caplyta's success in other conditions offers hope for similar positive outcomes. ^{1 2 3 4 5}

Who Is on the Research Team?

Jon E Grant, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Caplyta Experimental Treatment 1 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: Placebo Placebo Group 1 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.

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+

Published Research Related to This Trial

Second-generation medications have been found to be effective in treating symptoms of borderline personality disorder, particularly affective dysregulation and impulsive aggression, based on a review of open-label and placebo-controlled trials.

The findings suggest that treatment choices should prioritize medication tolerability and safety over the common practice of polypharmacy, which lacks empirical support for most patients with borderline personality disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on pharmacotherapy of borderline personality disorder. Zanarini, MC.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pharmacotherapy for borderline personality disorder (BPD) targets three main areas: affective dysregulation, impulsive-behavioral dyscontrol, and cognitive-perceptual symptoms, with SSRIs like fluoxetine and fluvoxamine recommended as first-line treatments for affective instability and impulsivity.

Recent studies show promise for mood stabilizers like valproate semisodium and atypical antipsychotics like olanzapine in managing symptoms of BPD, but more controlled trials with larger sample sizes are needed to confirm these findings and address existing gaps in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of pharmacotherapies for borderline personality disorder. Bellino, S., Paradiso, E., Bogetto, F.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for borderline personality disorder. Stoffers, J., Völlm, BA., Rücker, G., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05356013

NCT05356013 | Caplyta in Borderline Personality Disorder 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 ...

2. uchicagomedicine.org uchicagomedicine.org/find-a-clinical-trial/clinical-trial/irb210974

CLINICAL TRIAL / NCT05356013 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 ...

3. withpower.com withpower.com/trial/phase-2-personality-disorders-6-2022-89980

Caplyta for Borderline Personality Disorder 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 ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05356013/

Trial | NCT05356013 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 ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-2-borderline-personality-disorder-caplyta-trial-nct05356013

Caplyta in Borderline Personality Disorder A Phase 2 interventional study of Caplyta in Borderline Personality Disorder. Evaluating the Safety and Effectiveness of Caplyta in Adults with Borderline ...