Borderline Personality DisorderPhase 2NCT05356013
Caplyta in Borderline Personality Disorder
A Phase 2 study testing Caplyta in people with Borderline Personality Disorder, run by University of Chicago at 1 site in United States.
Trial summary
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Caplyta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18-65;
- Primary diagnosis of BPD
- Zanarini scale score of at least 9 at baseline
- Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy
- Ability to understand and sign the consent form.
Who cannot join
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Subjects with schizophrenia or bipolar I disorder
- Subjects with an active substance use disorder
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- 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).
Show all 9Show fewer
- Use of any new psychotropic medication started within the last 3 months prior to study initiation
- Previous treatment with Caplyta
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. 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 indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
Read the detailed description
Borderline personality disorder (BPD) is a serious, difficult to treat, psychiatric disorder that causes significant emotional distress, as well as resulting in significant economic burden to health care systems. A variety of psychotherapies, particularly dialectical behavior therapy (DBT) and systems training for emotional predictability and problem solving (STEPPS), have shown benefit in reducing many of the core symptoms of BPD. Healthcare systems, however, often lack the funding and appropriate expertise to implement these treatments, and finding trained DBT or STEPPS therapists has been difficult for many people with BPD. While research on the use of medication is ongoing, no drug has yet been approved in the United States or elsewhere for the treatment of BPD. Antidepressants, anti-convulsants, and second generation antipsychotics have all been examined, but current medication options for BPD often provide only partial relief and may have pronounced side effects.
BPD is characterized by a pervasive pattern of severe psychopathological symptoms with instability of affect regulation, impulse control, and aggression. Dysfunctions in the serotoninergic, dopaminergic, and glutamatergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder. Caplyta (lumateperone) therefore has distinctive properties that make it a promising option for patients with BPD. Caplyta is a mechanistically novel agent as it simultaneously modulates serotonin, dopamine, and glutamate, the key neurotransmitters implicated in BPD. Specifically, Caplyta acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor pre-synaptic partial agonist and post-synaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. In addition, because of low rates of side effects, Caplyta should be a well-tolerated and in fact desired medication approach to BPD.
The aim of the present study is to examine the efficacy and safety of Caplyta vs. placebo in adults with BPD, as indicated by a score of at least 9 on the Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale"), a scale of illness severity, at the baseline visit.
- Conditions
- Borderline Personality Disorder
- Being tested
- Caplyta, Placebo
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaplytaDrug
Also called lumateperone
Atypical antipsychotic
PlaceboDrug
Also called no other names
Pill that contains no medicine.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Caplyta | Experimental | 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. Receives: Drug: Caplyta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. The ZAN-BPD will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported.
Measured: 8 weeks
Secondary outcomes (10)
Change in Modified Overt Aggression Scale (MOAS) Total Score
The MOAS is a clinician-administered behavior rating scale measuring four types of aggressive behavior. The MOAS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. The total weighted scores range from 0-40, with 0 indicating no aggression. Higher total scores indicate higher aggression levels.
Measured: 8 weeks
Change in Young Mania Rating Scale (YMRS) Total Score
The YMRS is a clinician-administered, 11-item scale assessing manic symptoms at baseline and over time. The YMRS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-60) indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in participants.
Measured: 8 weeks
Change in Zanarini Rating Scale for Borderline Personality Disorder Self-Report Version (ZAN-BPD-SRV) Total Score
The ZAN-BPD-SRV is a self-report scale assessing borderline personality severity that will be assessed at all 5 visits. However, only the change from baseline to visit 5 at week 8 will be reported. Scoring is done by counting the number of yes's. Total scores range from 0-36, with higher scores indicating more severe symptoms. A score of 8 or more is indicative of a diagnosis of borderline personality disorder.
Measured: 8 weeks
Change in Borderline Evaluation of Severity Over Time (BEST) Total Score
The BEST is a self-rated scale used to measure severity and change. The first 12 items of the scale are scored on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept the participant from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. Items 13-15 are rated 1-5 with 5 indicating more frequent symptoms. The scale ranges from 12-72 with higher scores indicating more severe symptoms. The score for items 1-12 are added together, the score from items 13-15 are then subtracted, and then 15 is added to obtain the total score. The BEST will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported.
Measured: 8 weeks
Change in Barratt Impulsiveness Scale (BIS-11) Total Score
This BIS-11 is a self-report assessment of impulsivity that will be assessed at baseline and Visit 5. The change from baseline to visit 5 at week 8 will be reported. All items are added to result in a total score ranging from 30-120. Higher total scores indicate higher impulsiveness.
Measured: 8 weeks
Minnesota Impulsive Disorders Interview (MIDI)
The MIDI is a clinical interview that screens for a variety of impulsive disorders, including buying disorder, kleptomania, trichotillomania, intermittent explosive disorder, pyromania, gambling disorder, compulsive sexual behavior, binge eating disorder, and compulsive exercise. The results of the MIDI at baseline will be reported.
Measured: Baseline
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
The HAM-D is a clinician-administered assessment of depression that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-52) indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Measured: 8 weeks
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The HAM-A is a clinician-administered assessment of anxiety that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
Measured: 8 weeks
Change in Quality of Life Inventory (QOLI) Total Weighted Satisfaction Score
The QOLI is a self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 5. The change in total weighted satisfaction scores from baseline to visit 5 at week 8 will be reported. Higher scores (ranging from -96 to 96) indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
Measured: 8 weeks
Change in Sheehan Disability Scale (SDS) Total Score
Subjects will complete the SDS at all 5 visits. The change in total scores (ranging from 0-30) from baseline to visit 5 at week 8 will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 May 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Intra-Cellular Therapies, Inc.
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, MD, JD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356013
- Sponsor's protocol ID
- IRB21-0974
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2022
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05356013
- Acronym / sponsor ID
- IRB21-0974
- Conditions
- Borderline Personality Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Intra-Cellular Therapies, Inc.
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. 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 indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
Detailed description
Borderline personality disorder (BPD) is a serious, difficult to treat, psychiatric disorder that causes significant emotional distress, as well as resulting in significant economic burden to health care systems. A variety of psychotherapies, particularly dialectical behavior therapy (DBT) and systems training for emotional predictability and problem solving (STEPPS), have shown benefit in reducing many of the core symptoms of BPD. Healthcare systems, however, often lack the funding and appropriate expertise to implement these treatments, and finding trained DBT or STEPPS therapists has been difficult for many people with BPD. While research on the use of medication is ongoing, no drug has yet been approved in the United States or elsewhere for the treatment of BPD. Antidepressants, anti-convulsants, and second generation antipsychotics have all been examined, but current medication options for BPD often provide only partial relief and may have pronounced side effects.
BPD is characterized by a pervasive pattern of severe psychopathological symptoms with instability of affect regulation, impulse control, and aggression. Dysfunctions in the serotoninergic, dopaminergic, and glutamatergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder. Caplyta (lumateperone) therefore has distinctive properties that make it a promising option for patients with BPD. Caplyta is a mechanistically novel agent as it simultaneously modulates serotonin, dopamine, and glutamate, the key neurotransmitters implicated in BPD. Specifically, Caplyta acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor pre-synaptic partial agonist and post-synaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. In addition, because of low rates of side effects, Caplyta should be a well-tolerated and in fact desired medication approach to BPD.
The aim of the present study is to examine the efficacy and safety of Caplyta vs. placebo in adults with BPD, as indicated by a score of at least 9 on the Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale"), a scale of illness severity, at the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAll 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. |
| Caplyta | Experimental | Drug: CaplytaAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women age 18-65;
- Primary diagnosis of BPD
- Zanarini scale score of at least 9 at baseline
- Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy
- Ability to understand and sign the consent form.
Key exclusion criteria (9 listed)
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Subjects with schizophrenia or bipolar I disorder
- Subjects with an active substance use disorder
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaplytaAlso: lumateperoneAtypical antipsychotic | Drug | Caplyta |
| PlaceboAlso: no other namesPill that contains no medicine. | Drug | Placebo |
Primary outcome
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
Time frame: 8 weeks
The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. The ZAN-BPD will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported.
10 secondary outcomes
Change in Modified Overt Aggression Scale (MOAS) Total Score
Time frame: 8 weeks
Change in Young Mania Rating Scale (YMRS) Total Score
Time frame: 8 weeks
Change in Zanarini Rating Scale for Borderline Personality Disorder Self-Report Version (ZAN-BPD-SRV) Total Score
Time frame: 8 weeks
Change in Borderline Evaluation of Severity Over Time (BEST) Total Score
Time frame: 8 weeks
Change in Barratt Impulsiveness Scale (BIS-11) Total Score
Time frame: 8 weeks
Minnesota Impulsive Disorders Interview (MIDI)
Time frame: Baseline
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: 8 weeks
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: 8 weeks
Change in Quality of Life Inventory (QOLI) Total Weighted Satisfaction Score
Time frame: 8 weeks
Change in Sheehan Disability Scale (SDS) Total Score
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon E Grant, MD, JD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caplyta in people with Borderline Personality Disorder, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.