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Brexpiprazole in Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT03418675
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
University of Chicago

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
Borderline Personality Disorder Drug: Rexulti Drug: Placebo 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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

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 Name: Brexpiprazole




Primary Outcome Measures :
  1. Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: 13 weeks ]
    A clinician-administered scale assessing Borderline Personality Scale severity at all 9 visits


Secondary Outcome Measures :
  1. Modified Overt Aggression Scale (MOAS) [ Time Frame: 13 weeks ]
    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 [ Time Frame: 13 weeks ]
    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 9 visits.

  3. Self report version of Zanarini Scale [ Time Frame: 13 weeks ]
    A self-report scale assessing Borderline Personality severity that will be assessed at all 9 visits.This scale is assessing severity and change in BPD symptoms. Scoring is done by counting the number of yes's. A score of 8 or more is indicative of a diagnosis of borderline personality disorder.

  4. Borderline Evaluation of Severity Over Time (BEST) [ Time Frame: 13 weeks ]
    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. This scale will be assessed at all 9 visits.

  5. Barratt Impulsiveness Scale (BIS) [ Time Frame: 13 weeks ]
    A self-report assessment of impulsivity that will be assessed at baseline and visit 8. All items are added to result in a total score. Higher total scores indicate higher impulsiveness.

  6. Symptom Checklist-90 Revised [ Time Frame: 13 weeks ]
    An instrument that helps evaluate a broad range of psychological problems and symptoms of psychopathology. This will be assessed at baseline and visit 8.

  7. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 13 weeks ]
    A clinician-administered assessment of anxiety that will be assessed at all 9 study visits. Changes in scores from baseline to final visit will be assessed. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety.

  8. Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 13 weeks ]
    A clinician-administered assessment of depression that will be assessed at all 9 study visits. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.

  9. MINI International Neuropsychiatric Interview [ Time Frame: 13 weeks ]
    A short-structured interview that assesses psychiatric disorders according to the DSM V. This assessment will be done during the baseline visit.

  10. Sheehan Disability Scale (SDS) [ Time Frame: 13 weeks ]
    Subjects will complete the SDS at all 9 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.

  11. Quality of Life Inventory (QOLI) [ Time Frame: 13 weeks ]
    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.

  12. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 13 weeks ]
    A self-report scale measuring suicidality. Subjects will complete the scale at all 9 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418675


Contacts
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Contact: Stephanie Valle, BA 773-834-3778 valles@uchicago.edu
Contact: Elizabeth Cavic, BS 773-702-9066 ec642@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Stephanie Valle, BA    773-834-1325    svalle@yoda.bsd.uchicago.edu   
Contact: Jon E Grant, JD, MD, MPH    7738341325    jongrant@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Otsuka America Pharmaceutical
Investigators
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Chicago

Publications:
Gunderson J: Borderline Personality Disorder, 2nd ed. Washington, DC, American Psychiatric Press, 2000
Nakao K, Gunderson JG, Phillips KA, Tanaka N: Functional impairment in personality disorders. J Pers Disord 1992; 6:24-31
Nickel M, Leiberich P, Mitterlehner F: Atypical neuroleptics in personality disorders. Psychodynamic Psychotherapy 2003; 2:25-32
Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.
Frisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess. 4:92-101.
Barratt E: Anxiety and impulsiveness related to psychomotor efficiency. Percept Mot Skills 1959; 9:191-198
Derogatis LR: SCL-90-R Administration, Scoring, and Procedures Manual II. Towson, Md, Clinical Psychometric Research, 1983

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03418675     History of Changes
Other Study ID Numbers: 17-1729
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Disease
Pathologic Processes
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents