Clinical trial NCT04100096: A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
Official title: A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-24
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
timeFrame: Baseline (Day 0) to Week 10
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
timeFrame: Baseline (Day 0) to Week 10
measure: Change From Baseline in the Patient's Global Impression of Severity (PGI-S)
timeFrame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10 and 12
measure: Patient's Global Impression of Change (PGI-C) Scale Score
timeFrame: Weeks 2, 4, 6, 8,10 and 12
measure: Clinical Global Impression - Improvement (CGI-I) Scale Score
timeFrame: Weeks 2, 4, 6, 8, 10 and 12
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline (Day 0) to 21 days after last dose (Up to Week 15)
measure: Number of Participants With Potentially Clinically Relevant Laboratory Test Values
timeFrame: From first dose of study drug up to Week 12
measure: Number of Participants With Potential Clinical Relevant Laboratory Test Values - Prolactin
timeFrame: Week 12
measure: Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
timeFrame: From first dose of study drug up to Week 12
measure: Change From Baseline in Body Weight
timeFrame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline (Screening: Day -21 to Day -1), Week 12
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12
measure: Number of Participants With Potentially Clinically Relevant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters
timeFrame: Week 12
measure: Change From Baseline in Simpson-Angus Scale (SAS) Total Score
timeFrame: Baseline (Day 0), Week 6 and 12
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline (Day 0), Weeks 6 and 12
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
timeFrame: Baseline (Day 0), Weeks 6 and 12
measure: Number of Participants With Suicidal Behavior and Suicidal Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (Day 0) to Week 12
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research
state: Arkansas
city: Bellflower
country: United States
facility: CI Trials
state: California
city: Beverly Hills
country: United States
facility: Care Access Research Beverly Hills
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: San Rafael
country: United States
facility: SF-Care Inc.
state: California
city: Santa Ana
country: United States
facility: CI Trials
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Hartford
country: United States
facility: Institute of Living Hartford Hospital
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Boca Raton
country: United States
facility: Mindful Behavioral Health
state: Florida
city: Coral Springs
country: United States
facility: CNS Clinical Research of Coral Springs
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: APG Research
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Hospitals
state: Illinois
city: Naperville
country: United States
facility: AMR Conventions Research
state: Illinois
city: Winfield
country: United States
facility: Neuroscience Research Institute Inc.
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Bridgeton
country: United States
facility: Advanced Clinical Research Center, LLC
state: Missouri
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates dba Midwest Research Group
state: Missouri
city: Saint Louis
country: United States
facility: Arch Clinical Trials LLC
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials LLC
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: MindPath Care Centers
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake
state: Ohio
city: Mason
country: United States
facility: Lindner Center of Hope
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Charleston
country: United States
facility: Carolina Clinical Trials Inc.
state: South Carolina
city: Dallas
country: United States
facility: Relaro Medical Trials, LLC
state: Texas
city: Houston
country: United States
facility: Earle Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatric Associates
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Heath Science Center at San Antonio
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric Behavioral Solutions
state: Utah
city: Springville
country: United States
facility: Cedar Psychiatry
state: Utah
city: Woodstock
country: United States
facility: Woodstock Research Center
state: Vermont
city: Everett
country: United States
facility: Eastside Therapeutic Resource Inc dba Core Clinical Research
state: Washington
city: Sabadell
country: Spain
facility: Hospital Parc Taul Parc Tauli 1
state: Barcelona
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques - IMIM
city: Barcelona
country: Spain
facility: Consultoria i Projectes Sanitaris S.L. Clinic: Hestia Palau
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau Carrer de Sant Quint
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv railway clinical hospital 1
city: Odessa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health
city: Poltava
country: Ukraine
facility: Communal Enterprise-Regional Institution of Mental Psychiatric Care of the Poltava Regional Council
city: Vinnytsia
country: Ukraine
facility: Vinnitsa National Medical University
Study officials:
References:
citation: 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.