At a glance
This program funds early-stage clinical trials of novel investigational drugs and neuromodulatory devices for psychiatric disorders, including first-in-human, early feasibility, Phase Ib, and Phase II proof-of-concept studies. Eligible applicants include U.S. nonprofit and for-profit organizations, governments, tribal entities, schools, and other listed institutions, but foreign organizations and foreign components are not allowed. NIMH expects to commit a total of $27 million in FY 2026, and application budgets are not capped but must fit the project’s needs; the project period is up to one year for first-in-human drug studies, up to two years for Phase Ib, up to three years for Phase II/PoC, up to five years for both phases, and up to four years for device trials. The notice does not state a cost-share requirement, and it is limited to clinical trials of novel interventions for psychiatric disorders.
What it funds
Official description from grants.gov
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments