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Atypical Antipsychotic

Caplyta for Borderline Personality Disorder

Phase 2
Recruiting
Led By Jon E Grant, MD, JD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of BPD
Men and women age 18-65;
Timeline
Screening 1 day
Treatment 8 weeks
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will test if lumateperone (Caplyta) can reduce symptoms of Borderline Personality Disorder in adults. 60 people will be randomized to either Caplyta or placebo for 8 weeks.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for this trial are not listed, common side effects of Caplyta may include drowsiness, restlessness, and gastrointestinal issues. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with BPD as your main medical condition.
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You are between 18 and 65 years old, regardless of gender.

Timeline

Screening ~ 1 day
Treatment ~ 8 weeks
Follow Up ~8 weeks
This trial's timeline: 1 day for screening, 8 weeks for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Zanarini Rating Scale for Borderline Personality Disorder
Secondary outcome measures
Barratt Impulsiveness Scale (BIS)
Borderline Evaluation of Severity Over Time
Hamilton Anxiety Rating Scale
+8 more

Trial Design

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 Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Industry Sponsor
30 Previous Clinical Trials
7,471 Total Patients Enrolled
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,717 Total Patients Enrolled
3 Trials studying Borderline Personality Disorder
160 Patients Enrolled for Borderline Personality Disorder
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
9 Previous Clinical Trials
421 Total Patients Enrolled
1 Trials studying Borderline Personality Disorder
10 Patients Enrolled for Borderline Personality Disorder

Media Library

Caplyta (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05356013 — Phase 2
Borderline Personality Disorder Research Study Groups: Caplyta, Placebo
Borderline Personality Disorder Clinical Trial 2023: Caplyta Highlights & Side Effects. Trial Name: NCT05356013 — Phase 2
Caplyta (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05356013 — Phase 2
Borderline Personality Disorder Patient Testimony for trial: Trial Name: NCT05356013 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Caplyta gone through the necessary regulatory processes to be approved by the FDA?

"Although Caplyta has only completed Phase 2 trials, there is sufficient evidence to rate its safety at a 2 on our 3-point scale. Unfortunately no data can yet confirm efficacy."

Answered by AI

Is this trial accessible to those aged 55 or above?

"This medical trial is limited to those between 18 and 65 years old, however there are alternative trials available for younger or elderly patients; seven clinical trials cater to minors while 32 studies focus on seniors."

Answered by AI

Are there any available openings for participants in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this study is still actively recruiting participants. It was initially posted on May 10th 2023 and edited lastly 11 days later. The research team requires 60 subjects from one site in particular for enrolment into the trial."

Answered by AI

What is the upper bound of participants in this investigation?

"Confirming, the data accessible on clinicaltrials.gov attests that this investigation is proactively seeking participants. It was initially posted on May 10th 2023 and has been recently revised as of May 11th 2023. This experiment requires 60 individuals from 1 site to take part in it."

Answered by AI

Am I eligible to join the experimental study?

"Recruiting 60 individuals aged 18 to 65 with a diagnosis of borderline personality disorder, this trial has established certain prerequisites. These include: gender (male or female), baseline Zanarini score above 9, and regular cognitive behavioral therapy for the past two months in addition to comprehension of and consent for participating."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
California
Illinois
What site did they apply to?
University of Chicago Medical Center
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I Have BPD and it is a struggle living with it. I want to help researchers on this subject. I am a doctor.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Caplyta in Borderline Personality Disorder
2023. "Caplyta in Borderline Personality Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05356013.
All > Borderline Personality Disorder
~31 spots leftby Apr 2025
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