A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

NCT04100096 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 331-201-00242
• Study Type: interventional
• Target: 332
• Locations: 3 countries
• Sites: 77

Brief Summary

There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of participants diagnosed with BPD to provide a pharmacological treatment for BPD.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score

  The ZAN-BPD is a clinician-administered scale designed to assess severity of disease symptoms in participants with BPD based on clinician rating on 9 criteria. Each of the 9 criteria for BPD was rated on a 5-point anchored rating scale of 0 to 4. These scores were clustered into 4 sector scores (akin to domains) and a total score. The 4 sector scores added up to provide the overall total score for the ZAN-BPD, which ranged from 0 to 36. A higher score represented a higher severity of disease symptoms. Mixed model repeated measures = MMRM, antidepressant therapy = ADT.

  Baseline (Day 0) to Week 10

Secondary Outcomes (16)

• Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score

  Baseline (Day 0) to Week 10

• Change From Baseline in the Patient's Global Impression of Severity (PGI-S)

  Baseline (Day 0), Weeks 2, 4, 6, 8, 10 and 12

• Patient's Global Impression of Change (PGI-C) Scale Score

  Weeks 2, 4, 6, 8,10 and 12

• Clinical Global Impression - Improvement (CGI-I) Scale Score

  Weeks 2, 4, 6, 8, 10 and 12

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From Baseline (Day 0) to 21 days after last dose (Up to Week 15)

Study Arms (2)

Brexpiprazole 2-3 Milligrams Per Day

EXPERIMENTAL

Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.

Drug: Brexpiprazole

Placebo

PLACEBO COMPARATOR

Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.

Other: Placebo

Interventions

Brexpiprazole DRUG

Tablet

Also known as: Rexulti®

Brexpiprazole 2-3 Milligrams Per Day

Placebo OTHER

Tablet

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:

• Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
• Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
• At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
• Participants who, in the investigator's judgment, require treatment with a medication for BPD.
• Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.

You may not qualify if:

• Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
• Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
• Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
• Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
• Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
• Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
• Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
• Participants who have had 3 suicide attempts, OR,
• Participants who have had 3 or more hospitalizations due to suicidal behavior.
• Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
• Participants who are currently either inpatient or partially hospitalized.
• Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (77)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

CI Trials

Bellflower, California, 90706, United States

Location

Care Access Research Beverly Hills

Beverly Hills, California, 90212, United States

Location

OM Research LLC

Lancaster, California, 93534, United States

Location

CalNeuro Research Group

Los Angeles, California, 90024, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

PCSD - Feighner Research

San Diego, California, 92108, United States

Location

SF-Care Inc.

San Rafael, California, 94901, United States

Location

CI Trials

Santa Ana, California, 92705, United States

Location

Viking Clinical Research

Temecula, California, 90706, United States

Location

Pacific Clinical Research Management Group

Upland, California, 91786, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Institute of Living Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Mindful Behavioral Health

Boca Raton, Florida, 33431, United States

Location

CNS Clinical Research of Coral Springs

Coral Springs, Florida, 33067, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

New Life Medical Research Center

Hialeah, Florida, 33012, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, 32256, United States

Location

Innovative Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

Clinical Neuroscience Solutions dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

APG Research

Orlando, Florida, 32803, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30022, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

The University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

AMR Conventions Research

Naperville, Illinois, 60563, United States

Location

Neuroscience Research Institute Inc.

Winfield, Illinois, 60190, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Copley Clinical

Boston, Massachusetts, 02116, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Advanced Clinical Research Center, LLC

Bridgeton, Missouri, 63044, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

St. Charles Psychiatric Associates dba Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Arch Clinical Trials LLC

St Louis, Missouri, 63118, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

SPRI Clinical Trials LLC

Brooklyn, New York, 11235, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

MindPath Care Centers

Raleigh, North Carolina, 27606, United States

Location

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, 44012, United States

Location

Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

North Star Medical Research LLC

Middleburg Heights, Ohio, 44130, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73118, United States

Location

Carolina Clinical Trials Inc.

Charleston, South Carolina, 29407, United States

Location

Relaro Medical Trials, LLC

Dallas, Texas, 75243, United States

Location

Earle Research

Houston, Texas, 77058, United States

Location

Red Oak Psychiatric Associates

Houston, Texas, 77090, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

The University of Texas Heath Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Psychiatric Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

Cedar Psychiatry

Springville, Utah, 84663, United States

Location

Woodstock Research Center

Woodstock, Vermont, 05091, United States

Location

Eastside Therapeutic Resource Inc dba Core Clinical Research

Everett, Washington, 98201, United States

Location

Hospital Parc Taul Parc Tauli 1

Sabadell, Barcelona, 08208, Spain

Location

Institut Hospital del Mar d'Investigacions Mèdiques - IMIM

Barcelona, 08003, Spain

Location

Consultoria i Projectes Sanitaris S.L. Clinic: Hestia Palau

Barcelona, 08025, Spain

Location

Hospital de la Santa Creu i Sant Pau Carrer de Sant Quint

Barcelona, 08041, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Provincial de Zamora

Zamora, 49021, Spain

Location

Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

Kharkiv, 61068, Ukraine

Location

Kyiv railway clinical hospital 1

Kyiv, 1030, Ukraine

Location

Odessa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Communal Enterprise-Regional Institution of Mental Psychiatric Care of the Poltava Regional Council

Poltava, 36013, Ukraine

Location

Vinnitsa National Medical University

Vinnytsia, 21005, Ukraine

Location

Related Publications (2)

• Rothman B, Brewer C, Chang D, Hobart M, Hefting N, McQuade RD, Grant JE. A randomised study and an extension study of brexpiprazole in patients with borderline personality disorder. Acta Neuropsychiatr. 2024 Nov 19;37:e39. doi: 10.1017/neu.2024.31.

  PMID: 39558901 DERIVED

• Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

  PMID: 36375174 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: October 17, 2019
• Primary Completion: June 27, 2021
• Study Completion: June 27, 2021
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

UA (5); ES (6); US (66)