Accelerating Medicines Partnership - Schizophrenia (AMP SCZ)
The Accelerating Medicines Partnership (AMP) is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. The overall aim of the AMP Schizophrenia (SCZ) initiative is to generate tools that will considerably improve success in developing early-stage interventions for patients who are at risk of developing schizophrenia.
As part of this innovative collaborative partnership, all AMP SCZ data and analyses will be made available to the broad biomedical community through the NIMH Data Archive.
Schizophrenia is a serious mental illness that is associated with significant health, social, and economic concerns, and it is one of the top 15 leading causes of disability worldwide.
Schizophrenia is characterized by alterations to a person’s thoughts, feelings, and behaviors, which can include a loss of contact with reality known as psychosis. These symptoms typically emerge in adolescence or early adulthood and, if untreated, can be persistent and disabling, interfering with a person’s ability to engage in typical school, work, and social activities. Individuals with schizophrenia often experience a delay between diagnosis and the start of treatment—ranging from 1 to 3 years—which is often associated with poorer response to treatment and significantly worse long-term outcomes.
Detection and intervention before psychosis develops—when individuals are at clinical high risk (CHR) for psychosis—could attenuate, postpone, or even prevent the transition to psychosis and improve individuals’ clinical and functional outcomes.
AMP SCZ Approach
A core component of AMP SCZ is establishing a research network focused on CHR individuals, identifying biological markers, clinical endpoints, and other measures that predict disease trajectory and outcomes for this group. The initiative will also establish a Data Processing, Analysis, and Coordinating Center to allow researchers to integrate and analyze data from new and key existing CHR cohorts, with all data and analyses made publicly available through the NIMH Data Archive. The archive, established in 2006, is sustained on an ongoing basis through NIMH funds.
Findings from these studies will enable researchers to develop algorithms that predict the course of illness for CHR individuals, allowing for early intervention and testing of treatments that may prevent the development of schizophrenia and reduce the impact of CHR.
NIMH-Supported AMP SCZ Projects
NIMH is currently supporting three research projects as part of the AMP SCZ initiative:
- Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT)
Barnaby Nelson, Ph.D., head of ultra-high risk for psychosis research at the Center for Youth Mental Health at the University of Melbourne and at Orygen, Melbourne, Australia, and Patrick McGorry, M.D., Ph.D., head of the Center for Youth Mental Health at the University of Melbourne and executive director of Orygen, are leading a multisite project focused on developing models that can predict a wide range of clinical outcomes in CHR individuals. As part of this project, Nelson and colleagues will collect a diverse set of biomarkers along with clinical data to develop CHR trajectory-prediction tools that can be used to facilitate the selection of CHR individuals to enroll in clinical trials and monitor disease progression and outcomes.
- ProNET: Psychosis-Risk Outcomes Network
Scott Woods. M.D., professor of psychiatry at Yale University, and co-principal investigators Carrie Bearden, Ph.D., professor of psychiatry and biobehavioral sciences and psychology at the University of California, Los Angeles, and John Kane, M.D., professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, are leading a multisite project, including 26 international sites, mapping a wide range of biomarkers (including brain structure and function, psychopathology and cognition, genetics, behavior, and natural language and speech) onto a set of CHR trajectories and outcomes. Woods and colleagues will then test whether data-driven variation in these biomarkers can be used to predict individual clinical trajectories.
- Psychosis Risk Evaluation, Data Integration, and Computational Technologies (PREDICT): Data Processing, Analysis, and Coordination Center
Martha Shenton, Ph.D., professor of psychiatry and radiology at Harvard Medical School and Brigham and Women's Hospital, and Rene Kahn, M.D., Ph.D., chair of the Department of Psychiatry and Behavioral Health at Icahn School of Medicine at Mount Sinai, are leading a project creating a data processing, analysis, and coordination center that will integrate and analyze CHR biomarker and clinical data generated by the two multisite research networks (listed above) as well as key existing CHR-related datasets. Using these data, the researchers plan to develop algorithms that can identify biomarkers predictive of CHR outcomes — biomarkers that can then be used to identify clinically useful subtypes of CHR.
Accessing AMP SCZ Data
The NIMH Data Archive will provide cloud-based infrastructure to facilitate storage and analysis of AMP SCZ data. The data archive currently holds raw and derived data collected from a total of 500,000 research participants using a variety of measures, including clinical, imaging, electrophysiological, cognitive, genetic, and outcome measures.
All AMP SCZ data stored in the archive will adhere to the NIMH Data Archive terms and conditions and the NIMH Data Sharing Policy. Specifically, participant data will be aggregated in a privacy-enabled manner and will be protected by practices that include the removal of any personally identifiable information; accredited users will be given secure, role-based access to the data. The archive includes data dictionaries to describe and enable efficient searches across the diverse types of data.
AMP SCZ Partners and Governance
AMP SCZ private and non-profit partners include the American Psychiatric Association Foundation; Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Research & Development, LLC; National Alliance on Mental Illness; One Mind; Otsuka Pharmaceutical Development & Commercialization, Inc.; Schizophrenia & Psychosis Action Alliance; and Wellcome. These organizations will invest a combined total of $17 million over five years through the Foundation for the National Institutes of Health (FNIH), which manages the project.
NIMH will contribute $82.5 million over five years, pending availability of funds. Additionally, FDA will be a critical partner in providing regulatory guidance on biological markers of disease progression, outcome measures and endpoints for clinical trials.
The AMP SCZ steering committee (SC) is organized by FNIH and includes representatives from each of the partner organizations. The SC operates under the direction of the overall AMP Executive Committee and is responsible for defining and maintaining the research plan, reviewing progress of the project, and providing detailed assessment of milestones for AMP SCZ. Working groups created under the direction of the AMP SCZ SC will provide detailed technical analyses of key scientific, policy, or informatics issues that arise during implementation.