A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
Phase: PHASE2
Conditions: Borderline Personality Disorder
Sponsor: University of Chicago

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Date Submitted: June 15, 2021 
 
Principal Investigator:   
Jon Grant, JD, MPH, MD  
 
Title: Professor of Psychiatry & Behavioral Neuroscience 
Institution: University of Chicago 
Address: 5841 S. Maryland Avenue, Chicago, IL 60637 
Phone: 773-834-1325 
 
Title  
A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality 
Disorder. 
 
This project will take place at the University of Chicago.  Dr. Jon E. Grant, MD, JD is the 
Principal Investigator and can be phoned at 773-834-1325 or reached by email at 
jgrant4@bsd.uchicago.edu. 
 
This clinical trial will be conducted in the spirit of Good Clinical Practice and in accordance with 
this IRB-approved protocol.  No deviation from the protocol will be implemented without the 
prior review and approval of the IRB except where it may be necessary to eliminate an 
immediate hazard to a research subject.  In such a case, the deviation will be reported to the IRB 
as soon as possible. 
 
Objective  
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). 
 
Background of BPD 
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 (1–3). 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 (4–6).  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 (7-8). 
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 (9-17), but current medication options for BPD 
often provide only partial relief and may have pronounced side effects.  
 
Choice of Medication 

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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 (18-22). 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 (23-25). 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/Methodology  
Sixty individuals with a prior diagnosis of borderline personality disorder (BPD) will be 
recruited for a double-blind, placebo-controlled pilot study in which Caplyta or placebo is 
administered in a 1:1 fashion. All 60 subjects will have current BPD per DSM-5 criteria. 
Following baseline measures, subjects will receive Caplyta (42mg/day) or inactive placebo. 
Participants will be seen every 2 weeks during the 8-week period. At week 8, subjects will be 
discontinued from medication. Efficacy and safety measures will be performed at each visit.   
 
Study Population/Sample Size 
60 male and female outpatients aged 18-65 with a current primary diagnosis of BPD. 
 
Subjects 
 
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) 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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Advertisements will target this study population. Interested individuals will be asked to contact a 
study coordinator or complete an online survey expressing interest. Individuals will then undergo 
a phone screen before being scheduled for a first appointment. After being screened, potential 
subjects will be scheduled for a first appointment in which we will confirm medical and 
psychiatric history, laboratory tests, and inclusion/exclusion criteria.  
 
Drugs, Dosages, and Regimens  
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. 
 
Randomization 
 
Participants are randomized (1:1) to receive placebo or Caplyta by the investigational pharmacy 
at the University of Chicago. The study blind will be maintained by making placebo and active 
treatments appear identical in size, weight, shape, and color. Dosage changes and reductions will 
not be permitted during the study and participants will be discontinued if they experienced 
intolerance. 
 
Blinding 
 
Blinding is critical to the integrity of this clinical study. However, in the event of a medical 
emergency or pregnancy in an individual subject, in which knowledge of the investigational 
product is critical to the subject’s management, the blind for that participant may be broken by 
the treating physician. 
 
Treatment Duration, Visit Frequency, and Procedures   
This is an 8-week study (8 weeks of acute treatment). Subjects will be seen at baseline and then 
every two weeks after that for a total of 5 visits. 
 
Diagnostic Evaluation   
Psychiatric evaluation will use the MINI International Neuropsychiatric Interview with a module 
for BPD. 
 
Assessments at Each Visit 
Those subjects who appear appropriate for the study, based on telephone screening, will be 
invited for a baseline assessment. The duration of the baseline assessment will be approximately 
90-120 minutes and will include the following: Informed consent, Demographic data, 
Concomitant medications, Family history data, Medical evaluation including physical 
examination, labs, EKG, weight, and vital signs, Urine pregnancy test (for women of 
childbearing years) and urine drug screen, and a psychiatric evaluation (using the following 
measures: MINI International Neuropsychiatric Interview (26); Depressive symptoms will be 
rated with the 24-item Hamilton Depression Rating Scale (HAM-D) (27); Anxiety symptoms 
will be assessed using the Hamilton Anxiety Rating Scale (HAM-A) (28); Psychosocial 
functioning will be evaluated using the patient-rated version of the Sheehan Disability Scale 
(SDS) (29); Quality of Life Inventory (QOLI) (30); The Cambridge-Chicago Compulsivity Trait 
Scale (CHI-T); and the Columbia Suicide Severity Rating Scale (C-SSRS), Minnesota Impulse 
Disorders Interview (MIDI), Dietary Fat and Free Sugar Questionnaire, Sensory Gating 

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Inventory). During the consent process, individuals will be given time to review the consent form 
and given the opportunity to ask any questions that may arise before signing the informed 
consent form. Throughout the study, subjects will be asked questions about the study to ensure 
that they continue understanding study procedures. Blood samples will be collected at both 
baseline and last visits to measure fasting total cholesterol, high-density lipoprotein cholesterol, 
low-density lipoprotein cholesterol, glucose, insulin, triglycerides, prolactin levels, liver 
function, and kidney function. All follow-up visits will include safety measures (adverse events, 
vital signs, C-SSRS), weight, BPD measures, and other psychiatric measures. 
 
Efficacy evaluation 
The primary outcome measure will be the change from baseline using the Zanarini Rating Scale 
for Borderline Personality Disorder (“Zanarini scale”) (31). This semistructured interview has 
anchored ratings (0=no symptoms, 4=severe symptoms) on nine items that correspond to the 
DSM-5 BPD criteria. Its subscales will be considered secondary efficacy measures. 
 
Secondary efficacy measures include Modified Overt Aggression Scale (32), the Young Mania 
Rating Scale (33), and the self-report version of the Zanarini scale (34), the Borderline 
Evaluation of Severity Over Time (35), the Barratt Impulsiveness Scale (36) the  
Minnesota Impulsive Disorders Interview (37), the Symptom Checklist–90–Revised (SCL-90-R) 
(38), and the scales listed above (27-30). 
 
Cognitive Measures 
Cognitive assessments consist of three previously validated tests taken from CANTABeclipse 
software. The choice of cognitive challenges was based on the clinical features of BPD. The 
order of the tasks will be fixed and participants will complete the tasks at first visit (baseline), 
and week-8 endpoint. These cognitive tasks will be used for pilot data to examine possible 
cognitive mechanisms of action of Caplyta in adults with BPD. 
 
Cognitive flexibility, i.e., set-shifting, will be measured using the Intra-dimensional/Extra-
dimensional Shift Task (ID/ED task). Participants are presented with two stimuli on-screen for 
each trial and attempted to learn an underlying ‘rule’ about which stimulus was correct. Key 
outcome measures will be number of errors made at the intra-dimensional shift and at the extra-
dimensional shift stage.  
 
The Tower of London task will be used to examine executive planning. On each trial of the task, 
subjects observe two sets of pockets each containing three colored balls on-screen. On ‘move’ 
trials, subjects have to attempt to work out ‘in mind’ the minimum number of moves required to 
move the balls in one set of pockets to match a goal arrangement also shown in the other set of 
pockets.  
 
The Probabilistic Beliefs task will allow us to examine the subject’s self-other distinction. 
Participants observe a sequence of neutral images on the screen and are occasionally asked to 
make responses on a keyboard. Participants will be asked to keep track of the images they see 
and make predictions about what will happen next. They will also be asked to keep track of 
another theoretical person’s beliefs about what will happen next. The task will allow us to submit 
self-other distinctions, a potentially important dimension of BPD, to quantitative assessment and 
computational modelling. 
 
Subject Withdrawal 

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If a subject withdraws from the study, all instruments administered at the screening visit will be 
completed at the final visit.  These will be conducted when the subject is able to come in for an 
early termination visit.  Withdrawn subjects will be given the phone number of the principal 
investigator as well as the phone numbers of local resources for BPD treatment.   
 
Subject Termination 
If a subject fails to take the medication for a consecutive three-day period, they will be 
terminated from the study. In this case, the procedures for Subject Withdrawal will be followed 
(see above).  Medication compliance will be assessed via pill count and subject report. 
 
Safety Assessments 
Safety and tolerability will be assessed using spontaneously reported adverse events data, C-
SSRS, vital signs, and by evaluating premature termination.  Safety assessments (sitting blood 
pressure, heart rate, adverse effects, concomitant medications, and motor tolerability using the 
Abnormal Involuntary Movement Scale) will be documented at each visit. Subjects who are an 
immediate suicide risk will be removed from the study and appropriate clinical intervention (e.g. 
hospitalization) will be arranged. Study team members are mandated reporters and as such, will 
arrange for the subject to be taken to the emergency room if any intent to harm themselves is 
expressed. Urine pregnancy tests will be performed at the initial visit. Subjects who have a 
positive urine pregnancy test will be excluded from the study. Assessment of side effects will be 
done at each visit.  
 
Adverse Event Reporting 
Unanticipated (unexpected) problems/events, those that are not already described as potential 
risks in the consent form, or not part of an underlying disease, will be reported to the IRB as 
soon as possible.  The same will be done for serious problems/events and, in the opinion of the 
investigator, are possibly, probably or definitely related to the research procedures.  A follow-up 
report will also be submitted to the IRB with any documentation related to a previously 
submitted adverse event. 
 
Risks 
While taking the study drug, the subjects condition may remain the same or worsen due to no 
effect of the study drug. 
 
The most commonly reported side effects (greater than 2%) in previous clinical trials associated 
with Caplyta include: 
 
24% of subjects experience: 
• Somnolence/Sedation (Sleepiness) 
 
14% of subjects experience:  
• Headache 
 
6-10% of subjects experience: 
• Nausea 
• Dry Mouth 
• Extrapyramidal symptoms (which may include muscle spasms, stiffness, restlessness, 
tremor, and drooling, and may be irreversible) 

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• Increased total cholesterol and triglycerides 
 
3-5% of subjects experience: 
• Dizziness 
• Creatine Phosphokinase Increased (abnormal liver function tests) 
• Fatigue 
• Vomiting 
• Diarrhea 
• Blurred vision 
• Hyperglycemia (increased blood sugar levels) 
 
2% of subjects experience: 
• Hepatic Transaminases Increased (abnormal liver function tests) 
• Decreased appetite 
• Abdominal pain  
• Upper respiratory tract infection  
• Increased blood prolactin 
 
The following side effects have been experienced by some people who have used Caplyta 
outside of clinical trials. Because these reactions are reported voluntarily from a population of 
uncertain size, it is not always possible to reliably estimate how common these side effects are, 
or if they are related to the study drug. These reactions may be severe, life-threatening, or 
fatal, and include: 
These reactions may be severe, life-threatening, or fatal, and include: 
• Dystonia (abnormal contractions of muscles, may cause difficulty breathing) 
• Leukopenia (low white blood cell count) 
• Neutropenia (low amount of neutrophils in the blood) 
 
 
The following side effects have been experienced by people who have taken antipsychotics, 
which is the class of medication that Caplyta belongs to. These reactions may be severe, life-
threatening, or fatal, and include: These reactions may be severe, life-threatening, or fatal, 
and include: 
• Suicidal thoughts and behaviors 
• Increased risk of death in elderly people with dementia related psychosis 
• Stroke in elderly people with dementia-related psychosis that can lead to death 
• Weight gain 
• Orthostatic hypotension (low blood pressure that occurs upon standing) 
• Syncope (fainting) 
• Falls 
• Seizures 
• Body temperature dysregulation 
• Dysphagia (difficulty swallowing) 
 
It is possible that some of the questions we will ask you about BPD symptoms or mood might 
make the subject uncomfortable. They can decline to answer any questions that make them feel 
uncomfortable. 
 

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There may be other risks that could arise which are not reasonably foreseeable. If new 
information becomes available which could influence your willingness to continue, this new 
information will be discussed with the subject. 
 
Data Analysis 
Data analysis will involve all visits during the 8-week double-blind treatment phase (up until 
week 8).  
 
Data collected will consist of demographic data, subjective (self-report questionnaires, interview 
responses, ratings), physiological (heart rate and blood pressure), and cognitive (e.g., 
neurocognitive tasks). Access to individually identifiable private information about human 
subjects will be limited to Drs. Grant and Ehsan and their staff and will be collected specifically 
for the proposed research project. All collected data will be stored utilizing a 4-digit subject 
identification code, linked to separately stored identifying information via a coded log only 
available to the PIs.  
 
Prior to inferential analyses, descriptive statistics, including distributions, means, standard 
deviations, skewness, and kurtosis will be generated. Data will also be examined for the pattern 
and mechanism of missing data. Continuous data will be tested for normality and homogeneity 
of variance. The integrity of the randomization will be evaluated using t-tests for continuous 
variables and chi-square tests for categorical variables.  Further, baseline differences between 
those who enter the study and those who drop out before treatment will be evaluated. Subsequent 
outcome analyses will be adjusted for baseline differences using covariance procedures.  
 
All enrolled subjects will be included in the analyses of baseline demographics and safety 
according to an intent-to-treat (ITT) principle. For statistical analysis, the full-analysis set will be 
defined as all participants who took at least 1 dose of the study drug and had at least 1 post-
baseline primary efficacy assessment. The safety-analysis set will be defined as all randomized 
participants who took at least 1 dose of the study drug and completed at least 1 follow-up safety 
assessment.  
 
The statistical model will be a linear mixed-effects regression model (LME) that includes terms 
for treatment group, time, and treatment-by-time interaction.  The analyses will run using the 
nlme package on R for Windows (R Foundation, Vienna, Austria; http://www.r-project.org). 
Literature suggests LME without imputation may provide more accurate and stable results than 
LME models using fixed and multiple imputation methods for handling missing data, so no 
imputation will be undertaken for missing data. All tests of hypotheses will be performed using a 
two-sided significance level of 0.05.  
 
Sample Size 
The sample size was calculated for the primary endpoint of change from baseline. Assuming a 
similar magnitude of effect seen in other studies of medications for BPD, it was determined that 
25 participants would be needed in each treatment group to detect a difference with an overall 
5% type-I error risk. Given the particularly low rates of adverse events reported with Caplyta, as 
well as its more positive side effect profile in terms of weight gain, we expect few drop-outs 
from the study and therefore a smaller sample is needed (60 total).  
 
Data Handling and Record Keeping 

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All subject data will be maintained by the study personnel under the supervision of the principal 
investigator.  Subjects will be seen at the University of Chicago.  Patient binders will be kept in a 
locked room only accessible to research staff.   
 
Data and Safety Monitoring Plan 
1. Responsibility for Data and Safety Monitoring 
The PI will have overall responsibility for monitoring the integrity of study data and 
participant safety.  
2. Procedures for Monitoring Participant Safety 
The PI will implement the following procedures to ensure data integrity and the safety of 
participants during the study. 
• A number of elements of the research plan are intended to minimize the risks of 
study participation. If subjects become actively suicidal with intent and plan to 
kill themselves, the PI will evaluate them and refer them for immediate non-study 
treatment. Any participant endorsing suicidal thoughts with intent and plan will be 
immediately evaluated by the PI and referred to a higher level of care if clinically 
indicated.  
• The PI will evaluate patient safety and resolve any safety issues if necessary, as 
such issues arise. The PI will also be responsible for preparing written summary 
reports of adverse events and will prepare a written report summarizing any 
decisions that are made pertaining to participant disposition.  
• Data integrity and confidentiality will be safeguarded as stated above in the Data 
Handling and Record Keeping Section.  
 
3. Reporting Adverse Events 
• Any serious adverse event will be reported to the Institutional Review Board 
(IRB) at the University of Chicago in a full written report within 10 working days 
of the event. For fatal/life-threatening serious adverse events, the PI will notify 
the IRB Chair by phone immediately. 
• Any moderate adverse event which appears definitely, probably, or possibly 
related to study participation will be reported to the University of Chicago IRB in 
writing within 20 working days. 
• Any mild adverse event will be summarized in the IRB annual progress reports. 
 
Ethical Considerations 
This study will be conducted according to US and international standards of Good Clinical 
Practice (FDA regulations 21 CFR 312 for IND studies and FDA guidance E6) for all studies.  
Applicable government regulations and University of Chicago research policies and procedures 
will also be followed. 
 
This protocol and any amendments will be submitted to the University of Chicago Institutional 
Review Board (IRB) for formal approval to conduct the study.  The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator.   
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study.  This consent form will be submitted with the protocol for review and approval by the 
IRB.  The formal consent of a subject, using the IRB-approved consent form, will be obtained 
before that subject is submitted to any study procedure.  This consent form must be signed by the 

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subject or legally acceptable surrogate, and the investigator-designated research professional 
obtaining the consent.  
 
 

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