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

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    Recruiting
  • participants needed
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Updated on 19 February 2024

Summary

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.

Description

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).  

FAQ

You will receive the study drug and the medical testing needed for the study for free.  There are no costs to you or your insurance for the study drug and study procedures.  You will receive up to $100.00 for your time and to help cover your expenses for attending each study visit.

For more information about this clinical research study and the possible risks and benefits of participation, please call 215-544-3996 

Details
Condition attenuated psychosis syndrome,prodromal,clinical high risk,attenuated psychosis
Age 16years - 30years
Clinical Study IdentifierN/A
Last Modified on19 February 2024

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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