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Could a new pill ease borderline personality disorder symptoms?

NCT ID NCT05356013

Symptom relief Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tested whether Caplyta (lumateperone), a drug already used for other mental health conditions, can reduce symptoms of borderline personality disorder (BPD). Sixty adults with BPD received either Caplyta or a placebo pill for 8 weeks. Researchers measured changes in BPD symptom severity using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Caplyta (lumateperone), an atypical antipsychotic drug
What this could lead to
If it works, this could point toward a new medication option to ease symptoms of borderline personality disorder.
What could go wrong
This is a small, early-phase (Phase 2) study with only 60 participants. The drug may not prove more effective than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

May 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 of weekly cognitive behavioral therapy 5. Ability to understand and sign the consent form. Exclusion Criteria: 1. Unstable medical illness based on history or clinically significant abnormalities on baseline 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 childbearing potential 5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) 6. Illegal substance use based on urine toxicology screening (excluding marijuana given the 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 to study initiation 8. Previous treatment with Caplyta 9. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

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Conditions

The condition(s) this trial relates to.

borderline personality disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Borderline personality disorder

Contacts and locations

Locations

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.