Brexpiprazole in Borderline Personality Disorder

NCT03418675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-18

Study results available
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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

Interventions

DRUG

Placebo

Pill that contains no medicine

DRUG

Rexulti

Atypical antipsychotic

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY
  • University of Chicago

    lead OTHER

Principal Investigators

  • Jon E Grant, JD, MD, MPH · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2020-12-30
Completion
2021-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418675 on ClinicalTrials.gov