A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
- Conditions
- Borderline Personality Disorder
- Interventions
- Other: PlaceboDrug: Brexpiprazole
- Registration Number
- NCT04100096
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
- 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.
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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.
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Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
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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.
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Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
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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.
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Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
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Participants who are currently either inpatient or partially hospitalized.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase. Brexpiprazole 2-3 Milligrams Per Day Brexpiprazole Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score Baseline (Day 0) to Week 10 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score Baseline (Day 0) to Week 10 The severity of illness for each participant was rated using the CGI-S. CGI-S is an observer-rated scale with a total score range of 0 to 7 where a higher score represented a worse outcome. The response choices were 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Number of Participants With Potentially Clinically Relevant Laboratory Test Values From first dose of study drug up to Week 12 Laboratory parameters included hematology(Hem), serum chemistry(Che) and urinalysis(Uri). Criterion:Che-Alkaline Phosphatase (Units/liter \[U/L\]):≥3 x ULN, Aspartate Aminotransferase (U/L):≥3 x ULN,Bilirubin (mg/deciliter\[dL\]):≥2.0,Cholesterol(Cho);Cho,fasting(mg/dl):≥240,Creatine Kinase(U/L):≥3 x ULN, Creatinine(mg/dL):≥2.0,Glucose (Glu);Glu,fasting(mg/dL):100,High Density Lipoprotein (HDL) Cho (mg/dL):Male (M) \< 40or Female (F) \<50, Low Density Lipoprotein (LDL) Cho(mg/dL):≥160,Prolactin (nanograms/milliliter \[ng/mL\]):\>1 x ULN,Triglyceride (mg/dL):≥150,Urate(mg/dL): M ≥10.5 or F ≥8.5,Urea Nitrogen (mg/dL):≥30,Hem-Eosinophils (Eosi) (10\^9 L):≥10%,Hematocrit (%): M ≤37% and ≥3 percentage (per) point decrease from baseline or F≤32% and ≥3per point decrease from baseline, Hemaglobin(gram per deciliter \[g/dL\]):M ≤11.5 or F ≤9.5,Leukocytes(10\^9/L):≤2.8 x10\^3/uL,≤16.0 x10\^3/uL,Platelets(10\^9/L):≤75 x10\^3/ uL,≥700 x10\^3/uL,Uri-Glu,urine; Protein,urine:Increase of ≥2U.
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score Baseline (Day 0), Weeks 6 and 12 The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The global clinical evaluation was made on a 6-point scale, with zero representing absence of symptoms and a score of 5 representing severe akathisia.
Patient's Global Impression of Change (PGI-C) Scale Score Weeks 2, 4, 6, 8,10 and 12 A 7-point single-item self-report scale depicting a participant's rating of overall change in their condition since starting trial medication. Participants answered the question: "Since starting study medication, how much have their symptoms of Borderline Personality Disorder changed?" with a score ranging from 1 to 7 where 1 denoted very much improved and 7 denoted very much worse.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Baseline (Day 0) to 21 days after last dose (Up to Week 15) An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that started after start of study treatment.
Change From Baseline in Body Weight Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12 Change From Baseline in Waist Circumference Baseline (Screening: Day -21 to Day -1), Week 12 Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score Baseline (Day 0), Weeks 6 and 12 AIMS assessment consisted of 10 items describing symptoms of dyskinesia (muscles of facial expression, lips and perioral area, jaw, tongue, upper extremities, lower extremities, neck/shoulders/hips, overall movement severity, incapacitation, participant awareness). Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while participant was at rest (e.g., in waiting room), and study physician would make global judgments on participant's dyskinesia's (items 8 through 10). Each item was rated on 5-point scale of severity from 0 (none) to 4 (severe) and assessment of problems with teeth or dentures (yes = 1, no = 0) and if the participant normally wears dentures (yes = 1, no = 0). Total score ranged from 0 to 42. Higher scores indicated worst outcome.
Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs From first dose of study drug up to Week 12 Vital Signs included orthostatic hypotension, heart rate (HR), systolic and diastolic blood pressure (bp), and weight. Potential clinical relevance criterion: Orthostatic Hypotension:\>= 20 millimeters of mercury (mmhg) decrease in systolic bp and \>= 25 beats per minute (bpm) increase in HR from supine to standing; HR Standing (bpm):\< 50 and decrease \>= 15,\> 120 and increase \>= 15; HR Supine (bpm): \< 50 and decrease \>= 15,\>120 and increase \>= 15; Systolic BP Standing (mmhg):\< 90 and decrease \>=20,\> 180 and increase \>= 20; Systolic BP Supine (mmhg):\< 90 and decrease \>= 20, \>180 and increase \>= 20; Diastolic BP Standing (mmHg): \< 50 and decrease \>= 15,\> 105 and increase \>= 15; Diastolic BP Supine (mmHg):\< 50 and decrease \>= 15, \> 105 and increase \>= 15; Weight (kilograms\[kg\]): Decrease or increase \>= 7%. Only those categories with at least one participant with event are reported.
Number of Participants With Suicidal Behavior and Suicidal Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline (Day 0) to Week 12 Suicidality was monitored using the C-SSRS. Suicidality was defined as at least one occurrence of suicidal ideation (including wish to be dead, non-specific suicidal thought, suicidal ideation-no intent, ideation with intent, no plan, ideation with plan/intent) or at least one occurrence of suicidal behavior (actual attempt, non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts/behavior, suicidal behavior) for the assessment period.
Change From Baseline in the Patient's Global Impression of Severity (PGI-S) Baseline (Day 0), Weeks 2, 4, 6, 8, 10 and 12 PGI-S is a 7-point single-item self-report scale for the participant to rate the severity of symptoms of BPD ranging from 0 to 7 where 1 denoted no symptoms and 7 denoted very severe.
Clinical Global Impression - Improvement (CGI-I) Scale Score Weeks 2, 4, 6, 8, 10 and 12 Participant's condition was assessed using CGI-I scale. CGI-I is an observer-rated scale with a total score of 0 to 7 and a higher score represents a worse outcome. The score included the following response choices: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Number of Participants With Potential Clinical Relevant Laboratory Test Values - Prolactin Week 12 New onset (\> 1 x upper limit of normal {ULN}, \> 2 x ULN, 3 X ULN) prolactin means a participant who attains a categorical change during treatment phase but not at baseline. Only those categories with at least one participant with event are reported.
Change From Baseline in Body Mass Index (BMI) Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12 BMI is defined as weight in kilograms divided by the square of height in meters.
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters Week 12 ECG parameters analyzed included rhythm, conduction and ST/T morphology. Potential clinical relevance criterion: Rhythm- Supraventricular Premature Beat: not present at baseline and present post baseline, Ventricular Premature Beat: not present at baseline and present post baseline, Conduction- Right Bundle Branch Block: not present at baseline and present post baseline, ST/T Morphology- Symmetrical (Sym) T-Wave Inversion: not present at baseline and present post baseline. Only those categories with at least one participant with event are reported.
Change From Baseline in Simpson-Angus Scale (SAS) Total Score Baseline (Day 0), Week 6 and 12 The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of zero representing the absence of symptoms and a score of 4 representing a severe condition. The SAS total score was the sum of the scores for all 10 items and ranged from 0 to 40. Higher scores indicated worst outcome.
Trial Locations
- Locations (75)
Institute of Living Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Mindful Behavioral Health
🇺🇸Boca Raton, Florida, United States
University of Connecticut
🇺🇸Farmington, Connecticut, United States
Red Oak Psychiatric Associates
🇺🇸Houston, Texas, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
The University of Texas Heath Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
OM Research LLC
🇺🇸Lancaster, California, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Neuroscience Research Institute Inc.
🇺🇸Winfield, Illinois, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Galiz Research
🇺🇸Hialeah, Florida, United States
APG Research
🇺🇸Orlando, Florida, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
New Life Medical Research Center
🇺🇸Hialeah, Florida, United States
The University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Innovative Clinical Research, Inc
🇺🇸Lauderhill, Florida, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Jacksonville, Florida, United States
Paradigm Research Professionals
🇺🇸Oklahoma City, Oklahoma, United States
CI Trials
🇺🇸Santa Ana, California, United States
Manhattan Behavioral Medicine PLLC
🇺🇸New York, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
SPRI Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
Cedar Psychiatry
🇺🇸Springville, Utah, United States
Hospital Provincial de Zamora
🇪🇸Zamora, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Eastside Therapeutic Resource Inc dba Core Clinical Research
🇺🇸Everett, Washington, United States
Woodstock Research Center
🇺🇸Woodstock, Vermont, United States
Consultoria i Projectes Sanitaris S.L. Clinic: Hestia Palau
🇪🇸Barcelona, Spain
Arch Clinical Trials LLC
🇺🇸Saint Louis, Missouri, United States
Advanced Clinical Research Center, LLC
🇺🇸Bridgeton, Missouri, United States
Care Access Research Beverly Hills
🇺🇸Beverly Hills, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
SF-Care Inc.
🇺🇸San Rafael, California, United States
CalNeuro Research Group
🇺🇸Los Angeles, California, United States
The Medical Research Network, LLC
🇺🇸New York, New York, 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
Earle Research
🇺🇸Houston, Texas, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Psychiatric Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Vinnitsa National Medical University
🇺🇦Vinnytsia, Ukraine
Institut Hospital del Mar d'Investigacions Mèdiques - IMIM
🇪🇸Barcelona, Spain
Hospital Parc Taul Parc Tauli 1
🇪🇸Sabadell, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau Carrer de Sant Quint
🇪🇸Barcelona, Spain
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
🇺🇦Kharkiv, Ukraine
Communal Enterprise-Regional Institution of Mental Psychiatric Care of the Poltava Regional Council
🇺🇦Poltava, Ukraine
Odessa Regional Medical Centre of Mental Health
🇺🇦Odessa, Ukraine
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Kyiv railway clinical hospital 1
🇺🇦Kyiv, Ukraine
Hassman Research Institute, LLC
🇺🇸Berlin, New Jersey, United States
Clinical Neuroscience Solutions dba CNS Healthcare
🇺🇸Orlando, Florida, United States
Carolina Clinical Trials Inc.
🇺🇸Charleston, South Carolina, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Excell Research
🇺🇸Oceanside, California, United States
Pacific Clinical Research Management Group
🇺🇸Upland, California, United States
CNS Clinical Research of Coral Springs
🇺🇸Coral Springs, Florida, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
AMR Conventions Research
🇺🇸Naperville, Illinois, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, 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
Bioscience Research, LLC
🇺🇸Mount Kisco, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States