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

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

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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 day1 visit

Treatment ~ 8 weeks5 visits

Follow Up ~ 0 days0 visits

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.

0 / 2Eligibility criteria met