A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT04100096
Phase
PHASE2
Status
Completed

Conditions

  • Borderline Personality Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Brexpiprazole — DRUG
    Tablet
  • Placebo — OTHER
    Tablet

Study Details

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.

Key Dates

First listed
Sep 24, 2019
Start date
Oct 17, 2019
Status verified
Jun 2024
Primary completion
Jun 27, 2021
Completion
Jun 27, 2021

Study Design

Enrollment
332 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Placebo
    Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.

Primary Outcome Measure

Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score [ Time Frame: Baseline (Day 0) to Week 10 ]

Locations (66)

FacilityCityStateZIPSite coordinators
Pillar Clinical ResearchBentonvilleArkansas72712-
CI TrialsBellflowerCalifornia90706-
Care Access Research Beverly HillsBeverly HillsCalifornia90212-
OM Research LLCLancasterCalifornia93534-
CalNeuro Research GroupLos AngelesCalifornia90024-
Excell ResearchOceansideCalifornia92056-
PCSD - Feighner ResearchSan DiegoCalifornia92108-
SF-Care Inc.San RafaelCalifornia94901-
CI TrialsSanta AnaCalifornia92705-
Viking Clinical ResearchTemeculaCalifornia90706-
Pacific Clinical Research Management GroupUplandCalifornia91786-
Mountain View Clinical Research, Inc.DenverColorado80209-
University of ConnecticutFarmingtonConnecticut06030-
Institute of Living Hartford HospitalHartfordConnecticut06106-
Comprehensive Psychiatric CareNorwichConnecticut06360-
Mindful Behavioral HealthBoca RatonFlorida33431-
CNS Clinical Research of Coral SpringsCoral SpringsFlorida33067-
Gulfcoast Clinical Research CenterFort MyersFlorida33912-
Sarkis Clinical TrialsGainesvilleFlorida32607-
Galiz ResearchHialeahFlorida33016-
New Life Medical Research CenterHialeahFlorida33012-
Clinical Neuroscience Solutions Inc.JacksonvilleFlorida32256-
Innovative Clinical Research, IncLauderhillFlorida33319-
APG ResearchOrlandoFlorida32803-
Clinical Neuroscience Solutions dba CNS HealthcareOrlandoFlorida32801-
Institute for Advanced Medical ResearchAlpharettaGeorgia30022-
iResearch AtlantaDecaturGeorgia30030-
The University of Chicago HospitalsChicagoIllinois60637-
AMR Conventions ResearchNapervilleIllinois60563-
Neuroscience Research Institute Inc.WinfieldIllinois60190-
University of Kansas Medical CenterKansas CityKansas66160-
McLean HospitalBelmontMassachusetts02478-
Copley ClinicalBostonMassachusetts02116-
Adams ClinicalWatertownMassachusetts02472-
Rochester Center for Behavioral MedicineRochester HillsMichigan48307-
Advanced Clinical Research Center, LLCBridgetonMissouri63044-
Psychiatric Care and Research CenterO'FallonMissouri63368-
St. Charles Psychiatric Associates dba Midwest Research GroupSaint CharlesMissouri63304-
Arch Clinical Trials LLCSt LouisMissouri63118-
PsychCare Consultants ResearchSt LouisMissouri63128-
Hassman Research Institute, LLCBerlinNew Jersey08009-
Center for Emotional FitnessCherry HillNew Jersey08002-
Integrative Clinical TrialsBrooklynNew York11229-
SPRI Clinical Trials LLCBrooklynNew York11235-
Bioscience Research, LLCMount KiscoNew York10549-
Manhattan Behavioral Medicine PLLCNew YorkNew York10036-
The Medical Research Network, LLCNew YorkNew York10128-
Finger Lakes Clinical ResearchRochesterNew York14618-
New Hope Clinical ResearchCharlotteNorth Carolina28211-
MindPath Care CentersRaleighNorth Carolina27606-
Quest Therapeutics of Avon LakeAvon LakeOhio44012-
Lindner Center of HopeMasonOhio45040-
North Star Medical Research LLCMiddleburg HeightsOhio44130-
Paradigm Research ProfessionalsOklahoma CityOklahoma73118-
Sooner Clinical ResearchOklahoma CityOklahoma73112-
Carolina Clinical Trials Inc.CharlestonSouth Carolina29407-
Relaro Medical Trials, LLCDallasTexas75243-
Earle ResearchHoustonTexas77058-
Red Oak Psychiatric AssociatesHoustonTexas77090-
Pillar Clinical ResearchRichardsonTexas75080-
The University of Texas Heath Science Center at San AntonioSan AntonioTexas78229-
Grayline Research CenterWichita FallsTexas76309-
Psychiatric Behavioral SolutionsSalt Lake CityUtah84105-
Cedar PsychiatrySpringvilleUtah84663-
Woodstock Research CenterWoodstockVermont05091-
Eastside Therapeutic Resource Inc dba Core Clinical ResearchEverettWashington98201-

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By research site
Pillar Clinical Research· Bentonville, ARCI Trials· Bellflower, CACare Access Research Beverly Hills· Beverly Hills, CAOM Research LLC· Lancaster, CACalNeuro Research Group· Los Angeles, CAExcell Research· Oceanside, CA

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