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Trial record 2 of 2 for:    Borderline Personality Disorder Brexpiprazole

A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04100096
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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 subjects diagnosed with BPD to provide a pharmacological treatment for BPD.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Brexpiprazole Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
2-3 mg/day tablet
Drug: Brexpiprazole
Other Name: Rexulti®

Placebo Comparator: Placebo
Placebo tablet
Other: Placebo

Primary Outcome Measures :
  1. Change from baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score [ Time Frame: Up to 12 weeks ]
    A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms.

Secondary Outcome Measures :
  1. Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Up to 12 weeks ]
    An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome.

  2. Change from baseline in the Patient's Global Impression of Severity (PGI-S) for each trial visit during the double-blind treatment period [ Time Frame: Up to 12 weeks ]
    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.

  3. Patient's Global Impression of Change (PGI-C) Scale Score [ Time Frame: Up to 12 weeks ]
    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.

  4. Clinical Global Impression - Improvement (CGI-I) Scale Score [ Time Frame: Up to 12 weeks ]
    An observer-rated scale with a total score of 0 to 7. A higher score represents a worse outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects, ages 18 to 65, inclusive, at the time of informed consent
  • Subjects with a primary DSM-5 diagnosis of BPD confirmed by the SCID-5-PD at screening.
  • At screening and Day 0, subjects must have a total score ≥ 12 on the ZAN-BPD scale.
  • Subjects who, in the investigator's judgment, require treatment with a medication for BPD.
  • Subjects 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 IMP. Male or female subjects identifying as homosexual with exclusively homosexual partners may not be required to practice birth control methods following discussion with the investigator and medical monitor. Male subjects 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.
  • Subjects with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, subjects with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders. Subjects with MDD, PTSD, ADHD, panic disorder, or generalized anxiety can be included if symptoms have been stable, these disorders are not the primary focus of treatment and changes in any treatment for these disorders would not likely be required for the duration of the trial.
  • Subjects currently in psychotherapy specifically used to target BPD symptoms at time of screening.
  • Subjects who have had electroconvulsive treatment or transcranial magnetic stimulation.
  • Subjects with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
  • Subjects who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:

    • Subjects 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 subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 5, OR
    • Subjects with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
    • Subjects who have had 3 suicide attempts, OR,
    • Subjects who have had 3 or more hospitalizations due to suicidal behavior. Note that subjects who have engaged in non-suicidal self-injurious behavior within the 90 days prior to screening or at Day 0 are eligible, unless the behavior is better described as an actual attempt, interrupted attempt, or aborted attempt according to C-SSRS definition and/or investigator judgment and therefore exclusionary.

Subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 4 within the 90 days prior to screening or at Day 0 may be included following discussion with a medical monitor.

  • Subjects with hypothyroidism or hyperthyroidism or an abnormal result for free T4 at screening.
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
  • Subjects with uncontrolled hypertension, symptomatic hypotension, or orthostatic hypotension.
  • Subjects with epilepsy or a history of seizures, except for a single seizure episode.
  • Subjects who received brexpiprazole in any prior clinical trial or subjects who have taken or are taking commercially available brexpiprazole (Rexulti®).
  • Subjects with a history of neuroleptic malignant syndrome, serotonin syndrome, or clinically significant tardive dyskinesia.
  • Subjects with a history of true allergic response to more than 1 class of medication.
  • Subjects who are currently either inpatient or partially hospitalized.
  • Subjects 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.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT04100096     History of Changes
Other Study ID Numbers: 331-201-00242
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders
Pathologic Processes
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents