Status:
COMPLETED
Brexpiprazole in Borderline Personality Disorder
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 brexpipraz...
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) ...
Eligibility Criteria
Inclusion
- Men and women age 18-65;
- Primary diagnosis of BPD
- Zanarini scale score of at least 9 at baseline
- Ability to understand and sign the consent form.
Exclusion
- 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
- Initiation of psychological interventions within 3 months of screening
- Use of any other psychotropic medication
- Previous treatment with Brexpiprazole
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03418675
Start Date
November 26 2018
End Date
April 14 2021
Last Update
March 18 2022
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637