Accelerating Medicines Partnership – Schizophrenia (AMP SCZ)

Pioneering the identification of early indicators of schizophrenia to catalyze better treatment development for patients
 

The Problem
Research shows that early intervention in mental health conditions is linked to better health outcomes, but no tools exist to help identify people at early risk of developing schizophrenia.
The Solution
AMP Schizophrenia will transform the field by validating biomarkers needed to identify people at risk for schizophrenia.

Overview

The Accelerating Medicines Partnership – Schizophrenia (AMP SCZ) is the first neuropsychiatric project of the landmark Accelerating Medicines Partnership (AMP) program, managed by the Foundation for the National Institutes of Health (FNIH). This major public-private partnership between NIH’s National Institute of Mental Health (NIMH), the FNIH and private partner organizations from industry and nonprofit sectors addresses the critical need for more effective treatments for individuals with schizophrenia and related mental health conditions. This 5-year, $99.5 million global effort harnesses the combined capabilities of its public and private partners to develop early interventions for individuals experiencing mental illnesses in the psychosis spectrum domain, and to improve their quality of life by reducing symptom burden. 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 aims to develop tools to better define early stages of risk and to predict the likelihood of progression to psychosis and other undesired outcomes such as anxiety, depression and substance use disorders. Such tools will help identify novel drug targets and enable clinical trials to test new pharmacologic interventions that may prevent or delay the onset of psychosis in at-risk patients. 

Partners

Public-Sector Partners

  • European Medicines Agency (EMA)
  • National Institute of Mental Health (NIMH)
  • U.S. Food and Drug Administration (FDA)

Private-Sector Partners

  • American Psychiatric Association Foundation*
  • Boehringer Ingelheim*
  • Janssen Research & Development, LLC*
  • National Alliance on Mental Illness*
  • One Mind*
  • Otsuka Pharmaceutical Development & Commercialization, Inc.*
  • Schizophrenia & Psychosis Action Alliance*
  • Wellcome*

* Indicates partners that provide financial or in-kind support

Read what the partners are saying

FNIH Contacts

  • Eline Appelmans, M.D., MPH, BMedSci, Scientific Program Manager, Neuroscience, eappelmans@fnih.org
  • Noam Keren, M.A., Scientific Project Manager, Neuroscience, nkeren@fnih.org

About Schizophrenia

Schizophrenia profoundly impacts the health and wellbeing of individuals, caregivers and their communities. Schizophrenia is one of the top 15 leading causes of disability worldwide with an estimated average life lost of 28.5 years for individuals with the disorder in the United States. Affecting approximately 20 million people worldwide, schizophrenia is one of the most recognized yet least-understood brain disorders. People diagnosed with schizophrenia often exhibit widely different symptoms that may present or subside along different timelines. Schizophrenia is most often associated with distortions in thinking and behavior, including delusions and hallucinations. Less recognized, however, are persistent cognitive symptoms – such as social withdrawal and diminished emotional expression – that have a profound adverse effect on patients’ ability to function across many domains of life and that are not effectively treated by current medications.

Need for New Therapies

Improving researchers’ and clinicians’ understanding of this complex disorder is critical to developing new treatments. Although much is known about risk factors for schizophrenia, including genetic links and differences in brain structure and function, more tools (e.g., biomarkers and risk calculators) are needed to identify CHR individuals and to further differentiate subcategories of risk with increased accuracy and sensitivity. AMP SCZ will focus on those priority areas in order to refine and increase the success of clinical trials, enable better evaluations of treatment efficacy, and support early detection of risk and thus early intervention, all of which are key to improving patient outcomes. Dedicated funding from Wellcome, in combination with NIMH's significant contributions, will help AMP SCZ establish an international research network focused on CHR populations, enhancing the applicability of research results to global clinical trials aimed at helping the approximately 1.5 million people diagnosed with schizophrenia worldwide each year. Data generated by this research networkwill be housed in a data platform that will enable the broader biomedical research community to access and analyze these data, thereby further extending AMP SCZ’s reach and impact.

Data Access

A critical component of AMP SCZ is rapid dissemination of research data to the scientific community using the NIMH Data Archive (NDA) platform, allowing faster translation of findings into key tools and therapies. The NDA, which will provide cloud-based infrastructure to facilitate storage and analysis of AMP SCZ data, currently holds raw and processed data collected from approximately 500,000 research participants, including clinical, biological, genetic and outcome measures. The NDA will work with a Data Processing, Analysis and Coordinating Center to make data analysis pipelines available to the research community. 

Governance

The AMP SCZ steering committee (SC) is organized by the 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 AMP SCZ research plan, reviewing progress of the project and providing detailed assessment of project milestones for the AMP Executive Committee. AMP SCZ working groups will provide detailed technical recommendations to the SC for key scientific, policy, or informatics issues that arise during project execution.

AMP Approach

AMP SCZ joins four other AMP programs – focused on advancing discovery in Alzheimer’s disease, Parkinson’s disease, type 2 diabetes and rheumatoid arthritis and lupus – which are all coordinated by the FNIH. AMP partnerships, which were first launched in 2014, use cutting-edge scientific approaches to bring new medicines and supports to patients by enhancing validation of novel, clinically relevant therapeutic targets and biomarkers. Click here to learn more about AMP.

Goals

Early intervention and treatment of mental health conditions are tied to better health outcomes, but no tools currently exist to identify individuals at early risk of developing schizophrenia. This limitation makes it difficult to enroll CHR individuals in clinical trials, which in turn hinders the development of new treatments. AMP SCZ will transform research in CHR individuals and address crucial unmet patient needs by:

 

  • Spurring scientific discovery
    • AMP SCZ will validate biomarkers that are needed to identify CHR individuals and predict the likelihood of progression to psychosis and other outcomes. It will also enable the identification of these individuals for inclusion in clinical trials and pinpoint metrics that can be used to assess early signs of treatment efficacy.
  • Expanding reach
    • During its first three years, AMP SCZ will establish a research network with U.S. and international sites focused on CHR populations, making research results more applicable to clinical trials globally.
  • Setting the course for new research
    • Upon completion of the project, AMP SCZ will have created a research framework that lays a foundation for future development of faster, more robust interventions.
  • Connecting the field
    • AMP SCZ’s research data will be quickly disseminated to the broader scientific community through the NIMH Data Archive platform, allowing faster translation of findings into solutions.

Media

  • FNIH Press Release (September 15, 2020): Foundation for the NIH announces large-scale partnership to expedite treatments for schizophrenia Read more
  • NIH Press Release (September 15, 2020): NIH partnership aims to advance early intervention for individuals at risk of developing schizophrenia Read more