- Managed by FNIH, the study aims to define depression subtypes based on biology, enabling more individualized care.
- The program will establish the most comprehensive dataset for depression in history to accelerate future discoveries.
NORTH BETHESDA, Md.--(BUSINESS WIRE)--The Foundation for the National Institutes of Health (FNIH) today announced the launch of the first phase of a long-term study that will collect data across a broad set of measures to identify biomarkers for depression and more clearly define depression subtypes. This effort will move neuropsychiatry beyond diagnoses by symptoms alone and pave the way for more individualized care.
The initiative is launching with the support of partners representing academia, patient advocacy groups, philanthropists and life sciences companies, with the National Institute of Mental Health and the Food and Drug Administration serving in advisory roles. The project, named Multi-Modal Assessment and Phenotyping in Depression (MAP-D), ultimately aims to commit more than $70 million to the effort and is currently focused on the first $22 million for the three-year pilot phase of the program.
Urgent Need for Improved Definition, Diagnosis, and Treatment Approaches in Depression
“Depression is a growing public health issue and one of the defining health challenges of our time. It represents a heavy burden to society and families,” said Julie Gerberding, MD, MPH, President and CEO, FNIH. “We still lack reliable, practical tools to understand and measure this complex disease, and it will require a long-term, collaborative commitment from many organizations to deliver the right treatments and better outcomes.”
Over 21 million U.S. adults experience a major depressive episode each year, and depression costs an estimated $380 billion annually in healthcare, lost productivity and human suffering.
Too often, treatment for major depressive disorder takes a more generalized, trial-and-error approach, with the majority of patients failing to respond to initial treatments. The challenge of identifying the right therapy from the start is compounded by the fact that most antidepressants require weeks or months to achieve effective symptomatic relief.
Scope and Design of This Depression Study
The FNIH brought together a broad coalition of partners to design the study with strategic guidance and support from Alexandria Real Estate Equities, Inc., which was at the vanguard of catalyzing the public-private partnership. The study will generate the most comprehensive, integrated dataset assembled to date, combining multi-modal biomarker data—including genomics, neuroimaging, digital and clinical assessments and real-world, patient-reported outcomes—and will use custom AI models to link those biomarkers to patient outcomes over time. The data will help validate better tools to measure and track depression and other mental health conditions for both drug development and use in clinical care.
“Identifying biologically distinct subtypes of depression is one of the most important challenges facing mental health research today. The integration of multimodal biomarkers, digital measures, imaging, biological assays and clinical assessments has the potential to transform how we differentiate patients and guide treatment selection,” said Steve Hoffmann, MS, Senior Vice President, Chief Preclinical Officer, FNIH. “MAP-D is creating the evidence base and AI models needed to move from a one-size-fits-all approach toward precision-driven care that delivers the right treatment to the right patient at the right time.”
Over the first three years, this initiative will enroll more than 300 patients nationwide. The insights generated through the pilot will inform expansion to Phase 1b, with the potential to scale to more than 2,500 patients as the program grows and demonstrates success.
How MAP-D Will Address Barriers in Depression
A major impediment to progress in this field is that, for years, depression has been diagnosed as a single disease based on symptoms. Yet the underlying causes can vary from person to person, and symptoms can be accompanied by related conditions, such as anxiety, substance abuse, and chronic medical conditions.
MAP-D will rigorously profile thousands of individuals aged 15 and older with moderate to severe depression. Conditions that frequently occur alongside depression—such as PTSD and bipolar disorder—will also be studied together to better reflect real-world patient experience, helping researchers identify more precise subtypes and guide treatment decisions tailored to each person.
This initiative is supported by AbbVie, Alexandria Real Estate Equities, Inc., Alto Neuroscience, American Psychiatric Association Foundation, Circular Genomics, Cogstate Ltd, Definium Therapeutics, Eli Lilly and Company, Engrail Therapeutics, the National Alliance on Mental Illness (NAMI), and Neumarker Inc. and is funded in part through philanthropic support to the FNIH, including Julian Abdey. The FNIH gratefully acknowledges the academic researchers, investigators and subject matter experts who contributed scientific expertise to the MAP-D initiative, including Maurizio Fava, MD (Harvard University), Leanne Williams, PhD (Stanford University), Conor Liston, MD, PhD (Cornell University), and Katherine Burdick, PhD (Columbia University). For an updated list of partners and additional details about the project, go to https://fnih.org/our-programs/multi-modal-assessment-phenotyping-depression/.
About the Foundation for the National Institutes of Health
The FNIH builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health, life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health; and helps train the next generations of scientists. Established by Congress to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information, please visit fnih.org.
Contacts
Ryan Kirby
Ruder Finn, on behalf of the FNIH
908-499-9121
Ryan.Kirby@ruderfinn.com
