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Brexpiprazole in Borderline Personality Disorder

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT03418675
Collaborator
Otsuka America Pharmaceutical (Industry)
80
Enrollment
1
Location
2
Arms
28.6
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Borderline personality disorder is characterized by mood instability, cognitive symptoms, impulsive behavior, and disturbed relationships (1-3). A variety of psychotherapies have been developed (4-6) and, while research on the use of medication is ongoing, no drug has been approved in the United States or elsewhere for its treatment (7). Second generation antipsychotics have been the most intensively studied (8-11). Current treatments for BPD are often inadequate. Dialectical behavioral therapy has been shown to reduce BPD but finding trained psychologists is difficult.

Dysfunctions in the serotoninergic and dopaminergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder (25-28). Several studies on the use of traditional (29) and atypical antipsychotic agents in patients with borderline personality disorder (30-31) have shown a positive effect on individual symptoms (29, 32-36). However, we are not aware of any study evaluating Brexpiprazole in the treatment of patients with borderline personality disorder. In the proposed double-blind, placebo-controlled study, the influence of Brexpiprazole on the multifaceted psychopathological symptoms and aggression of patients with borderline personality disorder will be investigated.

Brexpiprazole therefore has distinctive properties that make it a promising option for patients with BPD. Brexpiprazole is a novel D2 partial agonist, has affinity for 5-HT1A, acts as an antagonist of the noradrenergic α1/2 receptor, partial agonist for D3, and antagonist for 5-HT2A (37-39). In addition, because of low rates of side effects, Brexpiprazole should be a well-tolerated and in fact desired medication approach to BPD.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled Study of Brexpiprazole in the Treatment of Borderline Personality Disorder.
Actual Study Start Date :
Nov 26, 2018
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Apr 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.

Drug: Placebo
Pill that contains no medicine
Other Names:
  • no other names

    		•
    Experimental: Rexulti

    1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.

    Drug: Rexulti
    Atypical antipsychotic
    Other Names:
  • Brexpiprazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Zanarini Rating Scale for Borderline Personality Disorder [Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)]

      A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.

    Secondary Outcome Measures

    1. Modified Overt Aggression Scale (MOAS) [Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)]

      A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.

    2. Young Mania Rating Scale [Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)]

      A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.

    3. Self Report Version of Zanarini Scale [Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)]

      A self-report scale assessing Borderline Personality severity that will be assessed at all visits.This scale is assessing severity and change in BPD symptoms. This is a 9-item scale measuring severity of different aspects of Borderline Personality Disorder, with each item rated on a 0-4 scale, 0=no symptoms, 4=severe symptoms. Total scores range from 0-36.

    4. Borderline Evaluation of Severity Over Time (BEST) [Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported]

      A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them 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. Completed at every visit.

    5. Barratt Impulsiveness Scale (BIS) [Baseline (Visit 1), Week 12 (Visit 8)]

      A self-report assessment of impulsivity that will be assessed at baseline and visit 8. The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: (Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4). These scores are summed to produce an overall impulsivity score ranging from 30 (not impulsive) to 120 (extremely impulsive).

    6. Symptom Checklist-90 Revised [Baseline, Visit 8 (Week 12)]

      An instrument that helps evaluate a broad range of psychological problems and symptoms of Borderline Personality Disorder psychopathology. This will be assessed at baseline and visit 8.The 115 items are rated by using a 5-step Likert scale (0=not at all, 4=very strong) and provide a global picture of borderline psychopathology. Global scores of borderline psychopathology are calculated by summing 12 items and range from 0-48. Higher scores indicate more severe symptoms of Borderline Personality Disorder.

    7. Hamilton Anxiety Rating Scale (HAM-A) [assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to Week 12) is reported]

      A clinician-administered assessment of anxiety that will be assessed at all study visits (Visit 1-Visit 8). Changes in scores from baseline to final visit will be assessed. Higher scores (up to 56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.

    8. Hamilton Depression Rating Scale (HAM-D) [Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported]

      A clinician-administered assessment of depression that will be assessed at all study visits (Visits 1-8). Higher total scores indicate higher levels of depression (up to 52), while a score of 0 would indicate no depressive symptoms.

    9. MINI International Neuropsychiatric Interview [Baseline (Week 1)]

      A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline visit.

    10. Sheehan Disability Scale (SDS) [Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)]

      Subjects will complete the SDS at all visits. The change in scores from baseline to study completion 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. Scores range from 0-30.

    11. Quality of Life Inventory (QOLI) [Baseline (Week 1), Week 12 (Visit 8)]

      A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. Participants are asked to rate the importance of each domain on a 3-point scale ranging from 1=not important to 3=very important, and to rate how satisfied they are with that domain on a 6-point scale, ranging from -3=very dissatisfied to +3=very satisfied. In scoring, importance ratings are multiplied by satisfaction ratings to produce weighted satisfaction scores for each of the 16 domains. Weighted satisfaction scores are summed and divided by the number of domains that were rated as important or very important to produce a raw score, which is then converted to a t-score, which provides a proxy measurement for perceived quality of life. T-scores range from very low perceived quality of life (0-36) to high perceived quality of life (58-77).

    12. Columbia Suicide Severity Rating Scale (CSSRS) [Baseline (Visit 1), Week 12 (Visit 8)]

      A self-report scale measuring suicidality. Subjects will complete the scale at all visits. Subjects are asked about suicidal thoughts. If answers are no, rater can proceed to "suicidal behavior" section where subject is asked about any non-suicidal self injurious behavior. If yes, subject is asked about intensity of ideations. In the event of serious threat to themselves, the subject will be escorted to the emergency room. Total score indicates severity of suicidal ideation and behavior, with lower scores representing lower levels of suicidality and higher scores representing higher levels of suicidality. A score of 0 would reflect no suicidality present, whereas a maximum score of 5 would reflect active suicidal ideation with intent to act.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    7. Initiation of psychological interventions within 3 months of screening

    8. Use of any other psychotropic medication

    9. Previous treatment with Brexpiprazole

    10. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • Otsuka America Pharmaceutical

    Investigators

    • Principal Investigator: Jon E Grant, JD, MD, MPH, University of Chicago

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT03418675
    Other Study ID Numbers:
    • 17-1729
    First Posted:
    Feb 1, 2018
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Personality Disorders
    Borderline Personality Disorder
    Brexpiprazole

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Period Title: Overall Study
    STARTED 40 40
    Completed All Baseline Measures 37 40
    Completed One-post Randomization Visit 34 35
    COMPLETED 25 30
    NOT COMPLETED 15 10

    Baseline Characteristics

    Arm/Group Title Placebo Rexulti Total
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic Total of all reporting groups
    Overall Participants 37 40 77
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    28.9
    30.9
    29.9
    Sex/Gender, Customized (Count of Participants)
    Female
    21
    56.8%
    24
    60%
    45
    58.4%
    Male
    12
    32.4%
    9
    22.5%
    21
    27.3%
    Other
    4
    10.8%
    2
    5%
    6
    7.8%
    Unknown/Not reported
    0
    0%
    5
    12.5%
    5
    6.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    8
    21.6%
    7
    17.5%
    15
    19.5%
    Not Hispanic or Latino
    13
    35.1%
    19
    47.5%
    32
    41.6%
    Unknown or Not Reported
    16
    43.2%
    14
    35%
    30
    39%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    5.4%
    1
    2.5%
    3
    3.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    2.5%
    1
    1.3%
    Black or African American
    6
    16.2%
    7
    17.5%
    13
    16.9%
    White
    22
    59.5%
    20
    50%
    42
    54.5%
    More than one race
    1
    2.7%
    2
    5%
    3
    3.9%
    Unknown or Not Reported
    6
    16.2%
    9
    22.5%
    15
    19.5%
    Education (Count of Participants)
    Less than HS diploma/GED
    0
    0%
    0
    0%
    0
    0%
    HS diploma/GED
    5
    13.5%
    7
    17.5%
    12
    15.6%
    Some college/Associates
    20
    54.1%
    18
    45%
    38
    49.4%
    Bachelors
    11
    29.7%
    9
    22.5%
    20
    26%
    Masters+
    0
    0%
    3
    7.5%
    3
    3.9%
    Unknown/ Not Reported
    1
    2.7%
    3
    7.5%
    4
    5.2%
    Employment Status (Count of Participants)
    Full-time
    11
    29.7%
    12
    30%
    23
    29.9%
    Part-time
    2
    5.4%
    3
    7.5%
    5
    6.5%
    Student
    8
    21.6%
    8
    20%
    16
    20.8%
    Unemployed
    15
    40.5%
    11
    27.5%
    26
    33.8%
    Retired
    0
    0%
    0
    0%
    0
    0%
    Other
    1
    2.7%
    1
    2.5%
    2
    2.6%
    Unknown/Not Reported
    0
    0%
    5
    12.5%
    5
    6.5%
    Marital Status (Count of Participants)
    Single
    31
    83.8%
    27
    67.5%
    58
    75.3%
    Married
    2
    5.4%
    3
    7.5%
    5
    6.5%
    Divorced/separated
    3
    8.1%
    6
    15%
    9
    11.7%
    Living together/engaged
    1
    2.7%
    1
    2.5%
    2
    2.6%
    Widowed
    0
    0%
    0
    0%
    0
    0%
    Unknown/Not reported
    0
    0%
    3
    7.5%
    3
    3.9%

    Outcome Measures

    1. Primary Outcome
    Title Zanarini Rating Scale for Borderline Personality Disorder
    Description A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.
    Time Frame Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects assigned to Placebo or Rexulti who completed one-post randomization visit.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 34 35
    Visit 1
    14.9
    14.9
    Visit 2
    7.6
    6.7
    Visit 3
    4.7
    5.3
    Visit 4
    6
    4.4
    Visit 5
    4.2
    4.5
    Visit 6
    5.7
    4.9
    Visit 7
    5
    4
    Visit 8
    8.4
    3.1
    2. Secondary Outcome
    Title Modified Overt Aggression Scale (MOAS)
    Description A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.
    Time Frame Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    No data displayed because data were not collected. Due to the outbreak of the COVID-19 pandemic and following restrictions, all study visits were moved to teleheath and only essential scales were completed.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 0 0
    3. Secondary Outcome
    Title Young Mania Rating Scale
    Description A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.
    Time Frame Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    No data displayed because data were not collected. Due to the outbreak of the COVID-19 pandemic and following restrictions, all study visits were moved to teleheath and only essential scales were completed.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 0 0
    4. Secondary Outcome
    Title Self Report Version of Zanarini Scale
    Description A self-report scale assessing Borderline Personality severity that will be assessed at all visits.This scale is assessing severity and change in BPD symptoms. This is a 9-item scale measuring severity of different aspects of Borderline Personality Disorder, with each item rated on a 0-4 scale, 0=no symptoms, 4=severe symptoms. Total scores range from 0-36.
    Time Frame Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects assigned to Placebo or Rexulti who completed one-post randomization visit.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 34 35
    Visit 1
    18.2
    17.6
    Visit 2
    12.8
    10.9
    Visit 3
    10.7
    7.9
    Visit 4
    10.7
    8.0
    Visit 5
    9.7
    7.0
    Visit 6
    9.6
    6.6
    Visit 7
    8.7
    6.0
    Visit 8
    9.3
    5.8
    5. Secondary Outcome
    Title Borderline Evaluation of Severity Over Time (BEST)
    Description A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them 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. Completed at every visit.
    Time Frame Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported

    Outcome Measure Data

    Analysis Population Description
    Subjects assigned to Placebo or Rexulti who completed the study.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Visit 1
    40.90
    (10.91)
    40.54
    (8.25)
    Visit 8
    29.15
    (8.37)
    23.15
    (9.06)
    6. Secondary Outcome
    Title Barratt Impulsiveness Scale (BIS)
    Description A self-report assessment of impulsivity that will be assessed at baseline and visit 8. The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: (Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4). These scores are summed to produce an overall impulsivity score ranging from 30 (not impulsive) to 120 (extremely impulsive).
    Time Frame Baseline (Visit 1), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed the study.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Visit 1
    76.53
    (15.33)
    72.27
    (15.50)
    Visit 8
    68.13
    (13.89)
    70.5
    (17.86)
    7. Secondary Outcome
    Title Symptom Checklist-90 Revised
    Description An instrument that helps evaluate a broad range of psychological problems and symptoms of Borderline Personality Disorder psychopathology. This will be assessed at baseline and visit 8.The 115 items are rated by using a 5-step Likert scale (0=not at all, 4=very strong) and provide a global picture of borderline psychopathology. Global scores of borderline psychopathology are calculated by summing 12 items and range from 0-48. Higher scores indicate more severe symptoms of Borderline Personality Disorder.
    Time Frame Baseline, Visit 8 (Week 12)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed the study.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Visit 1
    26.17
    (10.44)
    25.42
    (11.58)
    Visit 8
    20.25
    (7.99)
    14.21
    (10.88)
    8. Secondary Outcome
    Title Hamilton Anxiety Rating Scale (HAM-A)
    Description A clinician-administered assessment of anxiety that will be assessed at all study visits (Visit 1-Visit 8). Changes in scores from baseline to final visit will be assessed. Higher scores (up to 56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
    Time Frame assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to Week 12) is reported

    Outcome Measure Data

    Analysis Population Description
    Subjects assigned to Placebo or Rexulti who completed the study.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Mean (Standard Deviation) [change in score on a scale]
    -2.41
    (8.43)
    -4.88
    (7.46)
    9. Secondary Outcome
    Title Hamilton Depression Rating Scale (HAM-D)
    Description A clinician-administered assessment of depression that will be assessed at all study visits (Visits 1-8). Higher total scores indicate higher levels of depression (up to 52), while a score of 0 would indicate no depressive symptoms.
    Time Frame Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported

    Outcome Measure Data

    Analysis Population Description
    Subjects assigned to placebo or Rexulti who completed the study
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Mean (Standard Deviation) [change in score on a scale]
    -2.09
    (6.91)
    -3.81
    (7.41)
    10. Secondary Outcome
    Title MINI International Neuropsychiatric Interview
    Description A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline visit.
    Time Frame Baseline (Week 1)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed all baseline measures.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 37 40
    Major Depressive Episode (Current)
    16
    43.2%
    18
    45%
    Major Depressive Episode (Past)
    12
    32.4%
    18
    45%
    Manic Episode (Current)
    2
    5.4%
    2
    5%
    Manic Episode (Past)
    1
    2.7%
    3
    7.5%
    Hypomanic Episode (Current)
    1
    2.7%
    0
    0%
    Bipolar I Disorder (Current)
    0
    0%
    0
    0%
    Bipolar I Disorder (Past)
    0
    0%
    0
    0%
    Bipolar II Disorder (Current)
    0
    0%
    0
    0%
    Bipolar II Disorder (Past)
    0
    0%
    1
    2.5%
    Panic Disorder (Current)
    6
    16.2%
    6
    15%
    Panic Disorder (Lifetime)
    11
    29.7%
    10
    25%
    Agoraphobia (Current)
    7
    18.9%
    9
    22.5%
    Social Anxiety Disorder (Current)
    6
    16.2%
    9
    22.5%
    Obsessive Compulsive Disorder (Current)
    3
    8.1%
    3
    7.5%
    Post Traumatic Stress Disorder (Current)
    9
    24.3%
    12
    30%
    Alcohol Use Disorder (Past 12 months)
    13
    35.1%
    8
    20%
    Substance Use Disorder (Past 12 months)
    11
    29.7%
    8
    20%
    Any Psychotic Disorder (Current)
    0
    0%
    0
    0%
    Any Psychotic Disorder (Lifetime)
    0
    0%
    1
    2.5%
    Major Depressive Disorder with Psychotic Features (Current)
    0
    0%
    0
    0%
    Major Depressive Disorder with Psychotic Features (Past)
    0
    0%
    0
    0%
    Anorexia Nervosa (current)
    0
    0%
    1
    2.5%
    Bulimia Nervosa (Current)
    4
    10.8%
    4
    10%
    Binge Eating Disorder (Current)
    2
    5.4%
    4
    10%
    Generalized Anxiety Disorder (Current)
    10
    27%
    15
    37.5%
    Antisocial Personality Disorder (Lifetime)
    8
    21.6%
    4
    10%
    ADHD Combined Type (Current)
    2
    5.4%
    4
    10%
    ADHD Inattentive Type (Current)
    0
    0%
    1
    2.5%
    ADHD Hyperactive Type (Current)
    1
    2.7%
    1
    2.5%
    Tourette's Syndrome (Lifetime)
    0
    0%
    1
    2.5%
    Persistent Motor Tic Disorder (Lifetime)
    1
    2.7%
    1
    2.5%
    Provisional Vocal Tic Disorder (Lifetime)
    0
    0%
    0
    0%
    Provisional Tic Disorder (Lifetime)
    0
    0%
    0
    0%
    Specific Phobia
    4
    10.8%
    1
    2.5%
    Body Dysmorphic Disorder (Current)
    3
    8.1%
    2
    5%
    11. Secondary Outcome
    Title Sheehan Disability Scale (SDS)
    Description Subjects will complete the SDS at all visits. The change in scores from baseline to study completion 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. Scores range from 0-30.
    Time Frame Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed at least one post-randomization visit
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 34 35
    Visit 1
    17.3
    15.8
    Visit 2
    13.3
    10.7
    Visit 3
    11.5
    7.8
    Visit 4
    12.4
    7.8
    Visit 5
    11.7
    7.0
    Visit 6
    11.2
    7.9
    Visit 7
    12.0
    6.9
    Visit 8
    12.7
    7.7
    12. Secondary Outcome
    Title Quality of Life Inventory (QOLI)
    Description A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. Participants are asked to rate the importance of each domain on a 3-point scale ranging from 1=not important to 3=very important, and to rate how satisfied they are with that domain on a 6-point scale, ranging from -3=very dissatisfied to +3=very satisfied. In scoring, importance ratings are multiplied by satisfaction ratings to produce weighted satisfaction scores for each of the 16 domains. Weighted satisfaction scores are summed and divided by the number of domains that were rated as important or very important to produce a raw score, which is then converted to a t-score, which provides a proxy measurement for perceived quality of life. T-scores range from very low perceived quality of life (0-36) to high perceived quality of life (58-77).
    Time Frame Baseline (Week 1), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed all visits.
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 25 30
    Visit 1
    28.89
    (9.11)
    28.70
    (11.18)
    Visit 8
    30.75
    (10.62)
    35.71
    (6.43)
    13. Secondary Outcome
    Title Columbia Suicide Severity Rating Scale (CSSRS)
    Description A self-report scale measuring suicidality. Subjects will complete the scale at all visits. Subjects are asked about suicidal thoughts. If answers are no, rater can proceed to "suicidal behavior" section where subject is asked about any non-suicidal self injurious behavior. If yes, subject is asked about intensity of ideations. In the event of serious threat to themselves, the subject will be escorted to the emergency room. Total score indicates severity of suicidal ideation and behavior, with lower scores representing lower levels of suicidality and higher scores representing higher levels of suicidality. A score of 0 would reflect no suicidality present, whereas a maximum score of 5 would reflect active suicidal ideation with intent to act.
    Time Frame Baseline (Visit 1), Week 12 (Visit 8)

    Outcome Measure Data

    Analysis Population Description
    Subjects who completed all baseline data
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    Measure Participants 40 40
    Visit 1
    1.15
    (1.72)
    0.73
    (0.99)
    Visit 8
    0.23
    (0.66)
    0.08
    (0.35)

    Adverse Events

    Time Frame Through study completion, an average of 12 weeks.
    Adverse Event Reporting Description
    Arm/Group Title Placebo Rexulti
    Arm/Group Description 1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Placebo: Pill that contains no medicine 1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods. Rexulti: Atypical antipsychotic
    All Cause Mortality
    Placebo Rexulti
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Serious Adverse Events
    Placebo Rexulti
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/40 (2.5%) 0/40 (0%)
    Psychiatric disorders
    Suicidal Ideation 1/40 (2.5%) 1 0/40 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Rexulti
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 19/40 (47.5%) 11/40 (27.5%)
    Gastrointestinal disorders
    Nausea 6/40 (15%) 2/40 (5%)
    General disorders
    Fatigue 4/40 (10%) 2/40 (5%)
    Restlessness 3/40 (7.5%) 3/40 (7.5%)
    Dry Mouth 0/40 (0%) 3/40 (7.5%)
    Headache 2/40 (5%) 1/40 (2.5%)
    Sleep Problems 2/40 (5%) 0/40 (0%)
    Tremor 1/40 (2.5%) 0/40 (0%)
    Sweating 1/40 (2.5%) 0/40 (0%)
    Increase Appetite 1/40 (2.5%) 1/40 (2.5%)
    Psychiatric disorders
    Hallucinations 2/40 (5%) 0/40 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Jon E. Grant
    Organization University of Chicago
    Phone 7738341325
    Email jgrant4@bsd.uchicago.edu
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT03418675
    Other Study ID Numbers:
    • 17-1729
    First Posted:
    Feb 1, 2018
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022