Study for People at Risk of Psychosis

IRB/UVA Tracking #
Principal Investigator
Vishal Madaan
Kristina Muniz
Contact Phone
Official Trial Title
A Phase II randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 52-week treatment period as an early intervention in patients with attenuated psychosis syndrome.
Study Description

The Department of Psychiatry and Neurobehavioral Sciences, Division of Child and Family Psychiatry is seeking adolescents and adults ages 16-30 who may be at risk of experiencing psychosis in the future. The purpose of the study is to see if an investigational study drug prevents people with a specific type of mental illness (attenuated psychosis syndrome) from becoming worse.

You or your child may be eligible for this study if you or they are having trouble thinking clearly or concentrating, believing or hearing things that others do not, losing control of your thoughts, feeling nervous or anxious, feeling that others are “out to get” you, having trouble with family and friends, and/or having thoughts that scare you or the people around you.

This study involves 15 visits to the study center and 10 phone calls over a 14-month period. Various procedures will be done during these visits including physical exams, blood and urine testing, blood pressure, height, weight, ECG, pregnancy test (if female), video recorded interviews, and psychological assessments/ questionnaires.

If you or your child participate, study-related exams, tests, and the study drug will be provided at no charge.


Compensation may be available