Brexpiprazole in Borderline Personality Disorder

NCT03418675 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-1729
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• Zanarini Rating Scale for Borderline Personality Disorder

  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.

  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)

Secondary Outcomes (12)

• 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)

• 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)

• 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)

• 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

• Barratt Impulsiveness Scale (BIS)

  Baseline (Visit 1), Week 12 (Visit 8)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Rexulti

EXPERIMENTAL

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

Interventions

Rexulti DRUG

Atypical antipsychotic

Also known as: Brexpiprazole

Rexulti

Placebo DRUG

Pill that contains no medicine

Also known as: no other names

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (51)

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MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jon E. Grant
• Organization: University of Chicago

jgrant4@bsd.uchicago.edu

7738341325

Study Officials

• Jon E Grant, JD, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: November 26, 2018
• Primary Completion: December 30, 2020
• Study Completion: April 14, 2021
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)