At a glance
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.
What it funds
Official description from grants.gov
NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.
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