Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-11-26
Study Completion Date
2021-04-14
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Borderline Personality Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Groups
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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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Pill that contains no medicine
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.
Group Type
EXPERIMENTAL
Rexulti
Intervention Type
DRUG
Atypical antipsychotic
Interventions
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Rexulti
Atypical antipsychotic
Intervention Type
DRUG
Placebo
Pill that contains no medicine
Intervention Type
DRUG
Other Intervention Names
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Brexpiprazole
no other names
Eligibility Criteria
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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.
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Sponsor Role
collaborator
University of Chicago
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jon E Grant, JD, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-1729
Identifier Type: -
Identifier Source: org_study_id
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