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

Official funding announcement — preliminary draft

Funder: National Institutes of Health

Opportunity number: PAR-25-184

Official listed status: posted

Closing information: 2027-10-15 (official deadline clock time and time zone must be checked in NOFO)

Award disclosure: Applicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.

Applicant categories in federal synopsis: Private institutions of higher education; Special district governments; Public housing authorities/Indian housing authorities; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Public and State controlled institutions of higher education; For profit organizations other than small businesses; City or township governments; State governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Small businesses; Native American tribal governments (Federally recognized); Independent school districts; Native American tribal organizations (other than Federally recognized tribal governments); Others (see text field entitled "Additional Information on Eligibility" for clarification)

Federal synopsis

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.

Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.

Official Grants.gov opportunity and NOFO