A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
NCT ID: NCT04100096
Last Updated: 2024-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
332 participants
INTERVENTIONAL
2019-10-17
2021-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brexpiprazole 2-3 Milligrams Per Day
Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.
Brexpiprazole
Tablet
Placebo
Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.
Placebo
Tablet
Interventions
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Brexpiprazole
Tablet
Placebo
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Pillar Clinical Research
Bentonville, Arkansas, United States
CI Trials
Bellflower, California, United States
Care Access Research Beverly Hills
Beverly Hills, California, United States
OM Research LLC
Lancaster, California, United States
CalNeuro Research Group
Los Angeles, California, United States
Excell Research
Oceanside, California, 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
Viking Clinical Research
Temecula, California, United States
Pacific Clinical Research Management Group
Upland, California, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Institute of Living Hartford Hospital
Hartford, Connecticut, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Mindful Behavioral Health
Boca Raton, Florida, United States
CNS Clinical Research of Coral Springs
Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
New Life Medical Research Center
Hialeah, Florida, United States
Galiz Research
Hialeah, Florida, United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States
Innovative Clinical Research, Inc
Lauderhill, Florida, United States
Clinical Neuroscience Solutions dba CNS Healthcare
Orlando, Florida, United States
APG Research
Orlando, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
The University of Chicago Hospitals
Chicago, Illinois, United States
AMR Conventions Research
Naperville, Illinois, United States
Neuroscience Research Institute Inc.
Winfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
McLean Hospital
Belmont, Massachusetts, United States
Copley Clinical
Boston, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Advanced Clinical Research Center, LLC
Bridgeton, Missouri, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates dba Midwest Research Group
Saint Charles, Missouri, United States
Arch Clinical Trials LLC
St Louis, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Hassman Research Institute, LLC
Berlin, New Jersey, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Integrative Clinical Trials
Brooklyn, New York, United States
SPRI Clinical Trials LLC
Brooklyn, New York, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
MindPath Care Centers
Raleigh, North Carolina, United States
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, United States
Lindner Center of Hope
Mason, Ohio, United States
North Star Medical Research LLC
Middleburg Heights, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States
Carolina Clinical Trials Inc.
Charleston, South Carolina, United States
Relaro Medical Trials, LLC
Dallas, Texas, United States
Earle Research
Houston, Texas, United States
Red Oak Psychiatric Associates
Houston, Texas, United States
Pillar Clinical Research
Richardson, Texas, United States
The University of Texas Heath Science Center at San Antonio
San Antonio, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Psychiatric Behavioral Solutions
Salt Lake City, Utah, United States
Cedar Psychiatry
Springville, Utah, United States
Woodstock Research Center
Woodstock, Vermont, United States
Eastside Therapeutic Resource Inc dba Core Clinical Research
Everett, Washington, United States
Hospital Parc Taul Parc Tauli 1
Sabadell, Barcelona, Spain
Institut Hospital del Mar d'Investigacions Mèdiques - IMIM
Barcelona, , 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
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Provincial de Zamora
Zamora, , Spain
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
Odesa, , Ukraine
Communal Enterprise-Regional Institution of Mental Psychiatric Care of the Poltava Regional Council
Poltava, , Ukraine
Vinnitsa National Medical University
Vinnytsia, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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331-201-00242
Identifier Type: -
Identifier Source: org_study_id
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