The 1289-0032 Research Study for people at risk of psychosis

The 1289-0032 Research Study for people at risk of psychosis
Recruiting
16 years - 30 years
All
Phase 2
13 participants needed

Brief description of study

When psychosis develops, people often suffer symptoms, sometimes for many months. In some people, these symptoms may be an early sign that more serious mental health problems may develop.

The early symptoms may include:
-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
-having thoughts that scare you or the people are you

The purpose of this study is 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. This study tests whether BI 409306 prevents patients with a specific type of mental illness (attenuated psychosis syndrome) from becoming worse. This study looks at how well patients tolerate the medicine and how effective it is over 1 year.

Detailed description of study

You will visit the Hospital of the University of Pennsylvania (HUP) about 15 times and complete about 10 visits by phone (over 56 weeks) during the entire study.  At each visit, we will gather basic information about you.  For example, we may ask questions about your clinical symptoms, hospitalizations & other treatment, about your school, work & living situation, and about your satisfaction with your current treatment.  There are also several tasks you will complete at several visits: cognitive tests, physical exam, vital signs, blood work, a urine test, and an ECG (measures your heart activity).  

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: attenuated psychosis syndrome,prodromal,clinical high risk,attenuated psychosis
  • Age: 16 years - 30 years
  • Gender: All


Updated on 19 Feb 2024. Study ID: 828795

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