Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)

This program funds early-stage clinical trials of novel pharmacologic or neuromodulatory device-based interventions for mental disorders, using an R61/R33 phased design focused on target engagement and later functional outcomes. Applicants must be able to measure molecular or circuit target engagement objectively, and applications limited to only the R61 or only the R33 phase are not accepted. The R61 phase can support up to 2 years, and if milestones are met, the R33 phase can add up to 3 more years. The notice does not state an award count, and it does not give a single award size; it says all drugs and devices must have passed Phase I/EFS safety studies, and pediatric first-in-human or first-in-children studies must apply under a different funding opportunity.

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• Health
• Research & Discovery
• 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