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NCT05356013 · ClinicalTrials.gov registry record · Phase 2
Caplyta in Borderline Personality Disorder
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT05356013: Completed Phase 2 study, sponsored by University of Chicago.
NCT05356013 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05356013, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. The hypothesis to be tested is that Caplyta will result in greater rates of reduction in symptoms of BPD compared to placebo (improvement in symptoms will be indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
Primary Outcome
The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. The ZAN-BPD will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported.
Interventions
- DRUG Placebo
- DRUG Caplyta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-10 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the finished NCT05356013 record still lists
NCT05356013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05356013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05356013 about?
NCT05356013 is a clinical study titled "Caplyta in Borderline Personality Disorder". The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatm...
What is the current status of trial NCT05356013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-05-10. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT05356013?
The interventions under investigation include: Placebo (DRUG), Caplyta (DRUG).
Who is sponsoring clinical trial NCT05356013?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05356013's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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