At a glance
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A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
In Brief
A Phase 2 clinical trial evaluating Caplyta and Placebo for Borderline Personality Disorder. Completed, enrolled 60 participants across 1 site.
Signals
Detailed 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).
Study Details
Timeline
Arms & Interventions
All subjects who are randomized to Placebo will receive an identical placebo pill to the experimental drug starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. After study conclusion (week 8), the dose will be discontinued.
All subjects who are randomized to Caplyta will receive 42mg/day starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. Dosage changes and reductions will not be permitted. After study conclusion (week 8), the dose will be discontinued.
Interventions
Atypical antipsychotic
Pill that contains no medicine.