The NIH intramural research program has shifted all non-mission-critical laboratory operations to a maintenance phase in order to promote physical distancing and diminished transmission risk of COVID-19. Effective Monday, March 23, 2020, only mission-critical functions within NIH research laboratories will be supported.

Schizophrenia

Overview

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), and multiple public and private organizations. Managed through the Foundation for the NIH (FNIH), AMP aims to identify and validate the most promising biological targets for therapeutics.

The overall aim of AMP Schizophrenia (SCZ) is to generate tools that will considerably improve success in developing early stage interventions for patients who are at risk of developing schizophrenia.

AMP SCZ marks the first AMP initiative focused on a neuropsychiatric disorder and the fifth AMP initiative overall. As part of this innovative collaborative partnership, all AMP SCZ data and analyses will be made available to the broad biomedical community through the National Institute of Mental Health (NIMH) Data Archive.

About Schizophrenia

Schizophrenia is a serious mental illness that is associated with significant health, social, and economic concerns. Schizophrenia is one of the 15 leading causes of disability worldwide and individuals with the disorder are at increased risk of premature death relative to the general population. In the U.S., the estimated average potential life lost for individuals with schizophrenia is 28.5 years.

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.

Need for New Therapies

Detection and intervention before psychosis develops, when individuals are at clinical high risk for psychosis, could attenuate, postpone, or even prevent the transition to psychosis and improve individuals’ clinical and functional outcomes. AMP SCZ aims to develop measures that further define early stages of risk and predict the likelihood of progression to psychosis and other clinical outcomes. Such tools will enable clinical trials to test new pharmacologic interventions that may prevent or delay the onset of psychosis.

AMP SCZ partners will work toward the shared mission of discovering promising biological markers that can help identify those at risk of developing schizophrenia as early as possible, track the progression of symptoms and other clinical outcomes, including anxiety, depression, and substance use disorders, and define targets for treatment development.

AMP Approach

Advancing preventive interventions for schizophrenia will require a more complete understanding of the clinical and biological predictors in the early stages of the illness. AMP SCZ will harness the power of open science to accelerate the research and development process and advance promising therapies for individuals at risk of developing schizophrenia. By combining the expertise and resources of public and private partners, AMP SCZ will provide the support needed to determine which biomarkers show the greatest potential for predicting progression of the disease in clinical high risk individuals.

A core component of AMP SCZ is establishing a research network focused on individuals who are at clinical high risk, identifying biological markers, clinical endpoints, and other measures that predict disease trajectory and outcomes for this group. Additionally, a Data Processing, Analysis, and Coordinating Center will be created to allow researchers to integrate and analyze data from new and key existing clinical high risk cohorts, with all data and analyses made publicly available through the NIMH Data Archive. Findings from these studies will enable researchers to develop algorithms that predict the course of illness for clinical high risk individuals, allowing for early intervention and testing of treatments that may prevent the development of schizophrenia and reduce its impact.

Through rapid data sharing and integrated, collaborative research, AMP SCZ will enable proof-of-principle clinical trials to test tools and hypotheses that emerge from the initiative.

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. 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.

The NIMH Data Archive will work with the Data Processing, Analysis, and Coordinating Center to make data analysis pipelines available to the research community. The archive, which was established in 2006, is sustained on an ongoing basis through NIMH funds.

Governance

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.

Budget: 5 years ($99 Million Total Project Funding)

Disease area Total NIH funding ($M) Total Industry funding ($M) Total non-profit funding ($M) Total project funding ($M)
Schizophrenia 82.5 7.5 9
(+.062 in kind)
99
(+.062 in kind)

This page last reviewed on September 15, 2020