A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 1358894 once daily over 12 week treatment period in patients with borderline personality disorder
This study enrolls adults who have been diagnosed with borderline personality disorder. This study is being done to see if the study drug called, BI 1358894, may help people with BPD in the future.
You will be in this study for about 20 weeks, and will include 12 visits to the study center and about 6 visits via phone. The study will include physical exams, electrocardiograms (ECGs), urine tests , and blood tests. You will be asked to use an application (app) on a smartphone to answer questions and to take a selfie when the study drug is taken. You will also complete questionnaires and interviews. You will take the drug being tested for 12 weeks and/or placebo. A placebo looks like the study drug but has no drug in it. Neither you nor your doctor will know which you are taking. Study takes place at ECMC in Buffalo, NY.
The purpose of this study is to see if BI 1358894 compared to placebo is safe and effective in patients with BoPD to support dose selection for future studies.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Adults ages 18-65 years.
Diagnosed with Borderline Personality Disorder.
Due to COVID-19, new enrollment in research studies will be greatly limited.
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