Session Spotlight: AMP-Schizophrenia Sites Now Completing Collection of Biomarker Data

The 42 national and international sites participating in the Accelerating Medicine Partnerships-Schizophrenia (AMP-SCZ) completed enrollment in January of this year, said Carrie Bearden, Ph.D., principal investigator for the Psychosis Risk Outcomes Network of AMP-SCZ, during an Annual Meeting sesssion titled “Clinically Actionable Lessons From the Largest (and Ongoing) Study of Clinical High Risk for Psychosis.” She is also director of the Center for the Assessment and Prevention of Prodromal States at UCLA.

AMP-SCHZ, one of nine Accelerated Medicines Partnership projects, is a joint venture of the National Institute of Mental Health (NIMH), the National Alliance on Mental Illness, the pharmaceutical industry, and other nonprofit and private organizations, including the APA Foundation.

The AMP-SCZ sites exceeded their enrollment targets, with 2,109 individuals at clinical high risk for psychosis and 650 healthy controls now providing data. They will be tracked from baseline with a second biomarker assessment at two months and ongoing clinical follow-ups for two years.

Enrollment began in 2022. As of this past March, all clinical high risk (CHR) individuals and more than 90% of community controls had completed their baseline assessments. A total of 2,100 participants started their two-month assessment, while 866 started their one-year assessment.

Bearden, who also serves as director of the Center for the Assessment and Prevention of Prodromal States at UCLA, said that AMP-SCZ’s overarching goal is to develop a range of biomarkers “which can be used to identify new targets for drug-based treatments that can be tested in clinical trials.”

Also speaking at the session were John Torous, M.D., director of the digital psychiatry division in the psychiatry department at Beth Israel Deaconess Medical Center; Phillip Wolff, Ph.D., professor of psychology at Emory University; and Brandon Staglin, M.S., co-founder of One Mind, which is dedicated to the involvement of people with lived experience of mental illness in research. Staglin and others with experience of schizophrenia have been critical to the design and leadership of the project.

AMP-SCZ is employing sophisticated digital technology to collect de-identified data from participants, including “ecological momentary assessments” that will allow researchers to look at such things as exercise and mobility, sleep patterns, and access to green space. The project is also using advanced language analysis to examine how speech patterns during interviews and in daily patient recorded diaries may indicate risk for psychosis. All of these analyses, comprising thousands of data points, will be added to genetic, neurobiological, and imaging data to examine the association between biomarker and outcome.

Complementing the project is another NIMH-funded study, the Psychosis Risk Outcomes Compound Assessment Network (ProCAN), which will determine whether the biomarkers developed in AMP-SCZ respond to experimental compounds that can then be tested in clinical trials.

The search for biomarkers is a natural outgrowth of efforts dating back to the 1990s to identify individuals at high risk for psychosis. Collaboration between researchers and clinicians led to a consensus around a set of CHR and ultra high risk (UHR) criteria.

However, Bearden noted that one of the challenges associated with the criteria that AMP-SCZ aims to address is that just 15 to 25% of CHR individuals actually convert to psychosis, though many continue to have clinically relevant symptoms. Identification of biomarkers will help to clarify the various trajectories of at-risk individuals.

Bearden emphasized that all the data on biomarkers and outcomes will be open to clinicians and researchers at nda.nih.gov/ampscz. “AMP-SCZ will be a publicly available landmark dataset to guide the next generation of research and public health advances in CHR,” she said. ■

(Image: Getty Images/iStock/ipopba)