First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

Background
The National Institute of Mental Health (NIMH) is issuing this Notice of Funding Opportunity (NOFO) to support early stage clinical trials of novel investigational drugs or neuromodulatory devices aimed at treating psychiatric disorders. The goal is to address unmet medical needs and facilitate the rapid collection of data to 'de-risk' these interventions, thereby attracting further funding for clinical development as FDA-approved treatments. This initiative emphasizes the importance of collaborative partnerships between biomedical researchers and industry to enhance psychiatric drug and device development.

Grant Details
The NOFO supports milestone-driven early stage trials, including First-in-Human (FIH), Phase Ib, Phase II/Proof of Concept (PoC), and early feasibility studies (EFS) in both pediatric and adult populations. These studies must assess target engagement, safety, tolerability, and pharmacological effects. Specifically, FIH studies should evaluate safety and tolerability, target engagement, and pharmacological effects on relevant systems. Phase II/PoC studies must demonstrate clinical efficacy signals using pharmacologically-based dosing while validating target engagement in the brain. Neuromodulatory devices are also supported under this NOFO, requiring similar evaluations of safety and efficacy. The overall objective is to collect data that can inform future clinical development decisions.

Eligibility Requirements
Eligible applicants include higher education institutions (public or private), nonprofits, for-profit organizations (including small businesses), local governments, state governments, county governments, city or township governments, special district governments, Indian/Native American tribal governments (federally recognized or not), federal agencies including NIH intramural programs, independent school districts, public housing authorities, faith-based organizations, regional organizations.

Period of Performance
The project duration should be appropriate for the proposed study: one year for FIH studies; up to two years for Phase Ib studies; three years for Phase II/PoC studies; and a maximum of four years for device trials.

Grant Value
NIMH intends to commit a total of $27 million in FY 2026 for this NOFO and its companion opportunities. Application budgets are not limited but must reflect the actual needs of the proposed project.