The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), announced on April 21, the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new therapies for behavioral health. As part of the Trump Administration’s Executive Order to Accelerate Medical Treatments for Serious Mental Illness, EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.

A press release from HHS explained that EVIDENT is designed to catalyze a new era in mental and behavioral health treatments by generating FDA-ready clinical endpoints to validate the effectiveness of rapid-acting therapies, including digital interventions, neuromodulation, and neuroplastogens, as well as the safe use of psychedelics.

According to the news release, “the initiative will continue to make investments to gather, integrate, and analyze multimodal, longitudinal data from registered clinical trials and real-world care settings on a rolling basis. These research teams will help build the first generation of scalable, objective measures of behavioral health, enabling providers to move away from trial-and-error approaches of validating treatments and toward precise, personalized, data-driven care. These measures will also work to accelerate the regulatory approval of effective therapies, reducing the cost of developing interventions for Americans living with conditions such as depression, anxiety, addiction, and post-traumatic stress disorders.”

EVIDENT solicited proposals through four technical areas designed to answer four questions:

• What should we use for objective measurement?
• What is happening during treatment?
• Who will respond to what treatment?
• What is our shared data foundation?

The performer teams are led by:

• Alden Scientific, in Cambridge, MA, will provide multi-omics analysis (e.g., proteomics, genomics) to assess physiological changes that may also indicate mental health state and change.
• Attune Neurosciences, in San Francisco, will provide data and insights from the use of its low-intensity focused ultrasound to deliver neuromodulation therapy for chronic pain and depression.
• Motif Neurotech, in Houston, seeks to accelerate measures of neuromodulation by leading adjunctive data collection.
• NeuroFlow, Inc., Philadelphia, is developing a population-scale framework to evaluate rapid-acting behavioral health interventions against real-world standard-of-care baselines.
• INVI MindHealth, in Denver, is augmenting behavioral health research in neuromodulation and psychedelic therapies with a platform for real-time, objective biomarkers as new endpoints to rapidly determine treatment efficacy.
• Diamond Therapeutics, in Toronto, in partnership with Tactical Mind Research Coalition, in St. Petersburg, FL, will contribute data from a phase 2a clinical trial on psilocybin for generalized anxiety disorder.
• Duke University, in Durham, NC, will quantify cortisol, estradiol, interleukin 6 (IL 6), and interleukin 1β (IL 1β) from saliva samples to capture stress physiology, endocrine modulation, and inflammatory signaling.
• Holobiome in Boston will contribute data from a large-scale clinical trial to identify microbiome-modulating interventions targeting the gut-brain axis to reduce stress and anxiety.
• The Johns Hopkins University School of Medicine in Baltimore will contribute data from 8 approved clinical trials on psilocybin use across a range of conditions.
• Ksana Health, in Eugene, OR, will integrate continuous wearable device data with electronic health records at an unprecedented scale to predict and prevent behavioral health disorders and promote healthy behaviors.
• The University of Southern California, in Los Angeles, will contribute data from a trial on the feasibility and efficacy of psilocybin alone versus with eight weeks of mindfulness training in healthy adults.
• The University of Wisconsin, in Madison, will contribute data from 3 approved psilocybin trials, seeking to dissociate the contributions of conscious psychedelic experience and non-conscious neurobiological mechanisms, as well as examining whether transcutaneous auricular vagus nerve stimulation (taVNS) can augment durable outcomes following a single psilocybin session.
• The Yale Stress Center, in New Haven, CT, will contribute data from an interventional clinical trial testing the effects of pregnenolone in individuals with alcohol use disorder.