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NCT04100096 · ClinicalTrials.gov registry record · Phase 2
A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
NCT04100096: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04100096 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 332 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04100096, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
Study 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.
Primary Outcome
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 sym
Interventions
- OTHER Placebo
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2021-06-27 |
| Phase | Phase 2 |
What the finished NCT04100096 record still lists
NCT04100096 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04100096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04100096 about?
NCT04100096 is a clinical study titled "A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder". 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.
What is the current status of trial NCT04100096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2019-10-17. Estimated completion is 2021-06-27.
What interventions are being tested in trial NCT04100096?
The interventions under investigation include: Placebo (OTHER), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT04100096?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04100096's enrollment target sits among peer trials
332 144th of 2000 higher than 1,856 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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