← Back to Search

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 0 days
Awards & highlights

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.
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.
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
Select...
You have been diagnosed with BPD as your main medical condition.
Select...
You are between 18 and 65 years old, regardless of gender.

Timeline

Screening ~ 1 day
Treatment ~ 8 weeks
Follow Up ~0 days
This trial's timeline: 1 day for screening, 8 weeks for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Zanarini Rating Scale for Borderline Personality Disorder
Secondary study objectives
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
35 Previous Clinical Trials
9,272 Total Patients Enrolled
University of ChicagoLead Sponsor
1,037 Previous Clinical Trials
758,727 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
418 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
~26 spots leftby Oct 2025