Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

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.

✳ AI-generated summary — verify against the announcement

• Health
• Research & Discovery
• Children, Youth & Families
• Patients & People with Health Conditions
• Mental & Behavioral Health

• ✓ 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