Psychosis Risk Outcomes Network (ProNET)

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ProNET: Psychosis Risk
Outcomes Network, a project of the Accelerating Medicines Partnership for Schizophrenia

A global effort to better understand, treat, and prevent psychosis

(UCSF IRB#21-35345)

Study Overview

The Psychosis Risk Outcomes Network (ProNET) is a research study that aims to better understand the causes and course of the earliest stages of psychosis, focusing on the clinical high risk syndrome that sometimes progresses to first episode psychosis. For most, clinical high-risk symptoms, which are milder forms of symptoms of psychosis may stay the same, decrease or go away entirely over the course of a few months or a few years. For others, these symptoms may become more severe over time and develop into psychosis. The onset of psychosis disproportionately impacts young people, with the National Institute of Health (NIH) estimating that 100,000 young people experience a first episode of psychosis each year in the U.S.

ProNET is funded by the NIH and the Foundation for the NIH (FNIH) as an Accelerating Medicines Partnership (AMP), a program that brings together NIH, private foundations and industry sponsors to accelerate the development of new medications through large-scale research initiatives. ProNET builds upon the knowledge learned in previous studies demonstrating that early identification and treatment of psychosis produces better health outcomes, including reduced suicidal risk and symptom severity, improved long-term quality of life and lower economic burden.

ProNET represents the first worldwide, collaborative effort to understand and develop new treatments for the clinical high risk syndrome that sometimes progresses to psychosis. It’s a major step toward improving our diagnoses of mental health problems in young people and discovering how to prevent the development of more serious mental illnesses.

Daniel Mathalon, PhD, MD

Professor and ProNET Site Principal Investigator, UCSF

By studying a variety of biomarkers (brain scans and blood tests, for example), we aim to improve our ability to predict the health outcomes of individuals at clinical high risk, including which individuals are most likely to develop psychosis and which individuals are most likely to improve. The study, and the insights derived from it, will provide a platform for developing new treatments that aim to transform long-term outcomes for those at greatest risk for transitioning to psychosis — possibly altering the course of the illness or even preventing it altogether.

Take the mental health screener to see if you are eligible

Eligibility

Some individuals may be at higher risk of developing psychosis than others. This study is recruiting people who have experiences or circumstances that may put them at higher risk.

You may be eligible for this study if you live in or near the San Francisco Bay Area and meet the following criteria:

You are between the ages of 12-30 years old.

You are noticing a recent change in your thinking, behavior, or experiences, such as:

confusion about what is real or imaginary
feeling not in control of your own thoughts or ideas
feeling suspicious or paranoid
having experiences that may not be real, such as hearing sounds or seeing things that may not be there
having trouble communicating clearly

Most people who have these symptoms do not go on to develop psychosis. We are trying to understand why some people who have these experiences do develop psychosis while many others do not.

Frequently asked questions about participation

If I do participate in the study, what is required of me?

Participation in this study will include multiple visits to the UCSF Path Program Clinic and affiliated research centers over the course of two years. Some visits may be completed remotely.

To determine eligibility, you would first meet with a member of the ProNET study team for an interview.

If you are eligible to participate, study procedures include:

Clinical interviews: Clinical interviews focus on questions about your daily life, such as your friendships and school or work, and your experiences and symptoms. These interviews will happen roughly four times per year.
Biological assessments: This includes Magnetic Resonance Imaging (MRI) brain scans, electroencephalograms (EEG), and collection of saliva and blood samples.
Cognitive testing: These assessments focus on memory, attention, concencentration and learning.

What are the benefits of participating in this research study?

In addition to contributing to the advancement of knowledge about early psychosis, you’ll learn more about your own mental health. Through the clinical interview, you’ll receive an assessment of worrisome experiences you may be having and get recommendations for support. We can also share this information with your provider to help support your treatment options. This includes a brain MRI scan, so we can provide you with a picture of your brain.

You will also receive financial compensation of up to $1,300 for your participation in the study.

What are clinical high-risk symptoms and how do they differ from first episode psychosis?

The clinical high risk for psychosis syndrome includes symptoms that are similar to, but less severe than, the symptoms of first episode psychosis. Symptoms of the clinical high risk for psychosis syndrome include the emergence of unusual and unrealistic thoughts, feelings of suspiciousness toward others, feelings of special powers or abilities, hearing or seeing things that are not really there, and having trouble organizing thoughts.

These clinical high-risk symptoms are considered to reflect risk for psychosis but not psychosis itself, as long as the person experiencing them is uncertain about whether they are “real”. In first episode psychosis, individuals experience their symptoms as definitively real.

Why is this study important?

ProNET is a research study funded by the Accelerating Medicines Partnership (AMP) program—a major public-private partnership between the NIH, the FNIH, the U.S. Food and Drug Administration (FDA), and a number of pharmaceutical and life science companies, in addition to non-profit foundations and other organizations. Together, they aim to tackle urgent biomedical problems, with current initiatives including Alzheimer’s disease, Parkinson’s disease, Type 2 Diabetes, and most recently, Early Intervention in Schizophrenia.

AMP Schizophrenia (SCZ) marks a first-of-its-kind AMP initiative focused on a neuropsychiatric disorder and the fifth AMP initiative overall. AMP SCZ supports the ProNET study network and a second network based in Australia known as PRESCIENT that together represent 47 early psychosis programs across North America, Australia, Europe and Asia, making it the largest international research consortium to date dedicated to scientific advances in early psychosis.

The insights that result from the ProNET study will serve as the foundation for the development of treatments through AMP SCZ that can transform long-term outcomes for those at clinical high risk for developing first episode psychosis—possibly altering the course of the disease or even preventing first episode psychosis altogether.