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

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.

✳ AI-generated summary — verify against the announcement

• Health
• Research & Discovery
• Technology & Product Development
• Patients & People with Health Conditions
• Researchers & Scholars
• Biomedical & Disease Research
• 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