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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 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 60 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05356013
The ClinicalTrials.gov registry entry for NCT05356013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05356013 reports 0 study locations.
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.
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