A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100096
• Other study ID #: 331-201-00242
• Status: Completed
• Phase: Phase 2
• Start date: October 17, 2019
• Est. completion date: June 27, 2021

Study information

• Verified date: June 2022
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Brexpiprazole
Tablet

Other:
• Placebo
Tablet

Locations

Country	Name	City	State
Spain	Consultoria i Projectes Sanitaris S.L. Clinic: Hestia Palau	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau Carrer de Sant Quint	Barcelona
Spain	Institut Hospital del Mar d'Investigacions Mèdiques - IMIM	Barcelona
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Parc Taul Parc Tauli 1	Sabadell	Barcelona
Spain	Hospital Provincial de Zamora	Zamora
Ukraine	Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine	Kharkiv
Ukraine	Kyiv railway clinical hospital 1	Kyiv
Ukraine	Odessa Regional Medical Centre of Mental Health	Odessa
Ukraine	Communal Enterprise-Regional Institution of Mental Psychiatric Care of the Poltava Regional Council	Poltava
Ukraine	Vinnitsa National Medical University	Vinnytsia
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Quest Therapeutics of Avon Lake	Avon Lake	Ohio
United States	CI Trials	Bellflower	California
United States	McLean Hospital	Belmont	Massachusetts
United States	Pillar Clinical Research	Bentonville	Arkansas
United States	Hassman Research Institute, LLC	Berlin	New Jersey
United States	Care Access Research Beverly Hills	Beverly Hills	California
United States	Mindful Behavioral Health	Boca Raton	Florida
United States	Copley Clinical	Boston	Massachusetts
United States	Advanced Clinical Research Center, LLC	Bridgeton	Missouri
United States	Integrative Clinical Trials	Brooklyn	New York
United States	SPRI Clinical Trials LLC	Brooklyn	New York
United States	Carolina Clinical Trials Inc.	Charleston	South Carolina
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	The University of Chicago Hospitals	Chicago	Illinois
United States	CNS Clinical Research of Coral Springs	Coral Springs	Florida
United States	Relaro Medical Trials, LLC	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	Mountain View Clinical Research, Inc.	Denver	Colorado
United States	Eastside Therapeutic Resource Inc dba Core Clinical Research	Everett	Washington
United States	University of Connecticut	Farmington	Connecticut
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Institute of Living Hartford Hospital	Hartford	Connecticut
United States	Galiz Research	Hialeah	Florida
United States	New Life Medical Research Center	Hialeah	Florida
United States	Earle Research	Houston	Texas
United States	Red Oak Psychiatric Associates	Houston	Texas
United States	Clinical Neuroscience Solutions Inc.	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	OM Research LLC	Lancaster	California
United States	Innovative Clinical Research, Inc	Lauderhill	Florida
United States	CalNeuro Research Group	Los Angeles	California
United States	Lindner Center of Hope	Mason	Ohio
United States	North Star Medical Research LLC	Middleburg Heights	Ohio
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	AMR Conventions Research	Naperville	Illinois
United States	Manhattan Behavioral Medicine PLLC	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	Excell Research	Oceanside	California
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	APG Research	Orlando	Florida
United States	Clinical Neuroscience Solutions dba CNS Healthcare	Orlando	Florida
United States	MindPath Care Centers	Raleigh	North Carolina
United States	Pillar Clinical Research	Richardson	Texas
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	St. Charles Psychiatric Associates dba Midwest Research Group	Saint Charles	Missouri
United States	Arch Clinical Trials LLC	Saint Louis	Missouri
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Psychiatric Behavioral Solutions	Salt Lake City	Utah
United States	The University of Texas Heath Science Center at San Antonio	San Antonio	Texas
United States	PCSD - Feighner Research	San Diego	California
United States	SF-Care Inc.	San Rafael	California
United States	CI Trials	Santa Ana	California
United States	Cedar Psychiatry	Springville	Utah
United States	Viking Clinical Research	Temecula	California
United States	Pacific Clinical Research Management Group	Upland	California
United States	Adams Clinical	Watertown	Massachusetts
United States	Grayline Research Center	Wichita Falls	Texas
United States	Neuroscience Research Institute Inc.	Winfield	Illinois
United States	Woodstock Research Center	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score	A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms.	Up to 12 weeks
Secondary	Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score	An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome.	Up to 12 weeks
Secondary	Change from baseline in the Patient's Global Impression of Severity (PGI-S) for each trial visit during the double-blind treatment period	A 7-point single-item self-report scale for the patient to rate the severity of symptoms of BPD. A higher score denotes more severe symptoms.	Up to 12 weeks
Secondary	Patient's Global Impression of Change (PGI-C) Scale Score	A 7-point single-item self-report scale depicting a subject's rating of overall change in their condition since starting trial medication. With a higher score denoting a worse outcome.	Up to 12 weeks
Secondary	Clinical Global Impression - Improvement (CGI-I) Scale Score	An observer-rated scale with a total score of 0 to 7. A higher score represents a worse outcome.	Up to 12 weeks