Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04186403 · ClinicalTrials.gov registry record · Phase 2

Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

A Phase 2 study of Borderline Personality Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
201
Enrollment target
1
Study location

NCT04186403: Completed Phase 2 study of Borderline Personality Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT04186403 is a Phase 2 study of Borderline Personality Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 201 participants, above the 95-participant average among 16 other Borderline Personality Disorder trials with a reported enrollment target (112% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04186403, a Phase 2 study of Borderline Personality Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
201 participants
Enrollment target
1
Study location

Study Summary

This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.

Primary Outcome

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (I

Interventions

  • DRUG Brexpiprazole

Study Locations (1)

New York

  • For additional information regarding sites, contact 844-687-8522 - New York

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2020-01-13
Est. Completion 2021-09-22
Phase Phase 2

What the finished NCT04186403 record still lists

NCT04186403 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 16 other Borderline Personality Disorder trials with a reported enrollment target (112% higher).

The record links to 1 condition, with Borderline Personality Disorder appearing as the primary indexed condition, and to 1 intervention - of which Brexpiprazole is the first listed.

NCT04186403 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04186403 about?

NCT04186403 is a clinical study titled "Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)". This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.

What is the current status of trial NCT04186403?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2020-01-13. Estimated completion is 2021-09-22.

What conditions does trial NCT04186403 study?

This clinical trial studies the following conditions: Borderline Personality Disorder.

What interventions are being tested in trial NCT04186403?

The interventions under investigation include: Brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT04186403?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04186403 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Borderline Personality Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04186403's enrollment target sits among peer trials

201 2nd of 16 the highest of 16 other Borderline Personality Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Borderline Personality Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04422652 · 201 participants · Phase 2

    Combination of Novel Therapies for CKD Comorbid Depression

  • NCT05327114 · 201 participants · Phase 2

    Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

  • NCT06099769 · 201 participants · Phase 2

    A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

  • NCT06274528 · 201 participants · Phase 2

    DORA and LP in Alzheimer's Disease Biomarkers

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04186403, the US trial registry maintained by the National Library of Medicine. NCT04186403 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.