Accelerating Medicines Partnership® Program – Schizophrenia
Improving treatments for patients by identifying early indicators of schizophrenia
The Accelerating Medicines Partnership® (AMP®) Program Schizophrenia (AMP SCZ) is the first neuropsychiatric project of the landmark AMP program, managed by the Foundation for the National Institutes of Health. This major public-private partnership between NIH’s National Institute of Mental Health (NIMH) 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. The project 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.
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 28.5 years of life lost, on average, 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 (matched by NIMH) will help 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 network will be housed in a data platform that will enable the broader biomedical research community to access and analyze these data, thereby further extending the project’s reach and impact.
AMP SCZ Opportunities
Donations to the FNIH can be designated for schizophrenia research.
- European Medicines Agency (EMA)
- National Institute of Mental Health (NIMH)
- U.S. Food and Drug Administration (FDA)
- 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*
* Provided financial and/or in-kind support for this project.
- Elizabeth Marden, M.F.S., Scientific Project Manager, Neuroscience, email@example.com
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.
Read more about AMP SCZ on the National Institute of Mental Health’s website.
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:
- Validating biomarkers that are needed to identify CHR individuals, predict the likelihood of progression to psychosis and other outcomes, and pinpoint metrics that can be used to assess early signs of treatment efficacy.
- Establishing a research network with U.S. and international sites focused on CHR populations, making research results more applicable to clinical trials globally.
- Enabling the identification of CHR individuals for inclusion in clinical trials.
- Creating a research framework that lays a foundation for future development of faster, more robust interventions.
- Disseminating research data to the broader scientific community through the NIMH Data Archive platform, allowing faster translation of findings into solutions.
Leading Science with Lived Experience – Schizophrenia Bulletin
FNIH Newsletter (November 30, 2022): Living with Schizophrenia, and Thriving: A Conversation with Carlos Larrauri
FNIH Press Release (September 15, 2020): Foundation for the NIH announces large-scale partnership to expedite treatments for schizophrenia
NIH Press Release (September 15, 2020): NIH partnership aims to advance early intervention for individuals at risk of developing schizophrenia
ACCELERATING MEDICINES PARTNERSHIP and AMP are registered service marks of the U.S. Department of Health and Human Services.