Brexpiprazole in Borderline Personality Disorder

• Status: Completed
• Trial end date: 2021-04-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Brexpiprazole

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