At a glance
This program funds confirmatory efficacy clinical trials of non-pharmacological interventions and, under certain conditions, pharmacological interventions for mental disorders in adults and children. It supports therapeutic and preventive studies that have already shown target engagement, target validation, and an initial signal of efficacy, and it is aimed at interventions with a compelling scientific rationale. Eligible applicants include a wide range of U.S. and non-U.S. organizations, including nonprofits, universities, governments, businesses, tribal entities, and foreign organizations. NIMH plans to commit a total of $27,000,000 for FY 2026, application budgets are not limited but must fit the project needs, the maximum project period is 5 years, and no cost sharing is required. Foreign organizations and foreign components of U.S. organizations are allowed.
What it funds
Official description from grants.gov
Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.
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