National Institutes of Health · Department of Health and Human Services
Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)
Key facts
- Deadline
- Due Oct 15, 2027 · 373 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- State government, Larger business, Special district (utility, fire, etc.), County government, Tribal government, Nonprofit with 501(c)(3), Private college or university, Small business, City or town government, Public college or university, Tribal organization, School district, Nonprofit without 501(c)(3), and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No match required
- Past Tennessee awards on file: 99
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/5e20d263-9eee-432b-bbfe-ba53e73b13da · Printed from grantme.click/grants/59f1d21c-a0d4-4487-b77f-34c918b8607d
View on Grants.gov Add deadline to my calendar
More from National Institutes of Health
- Systematic Characterization of Genomic Variation to Assess Effects of Individual Variants on Genome Function and Phenotype (UM1 Clinical Trials Not Allowed) · The funder's estimated date (Jul 15, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
- IGVF Data and Coordinating Center (U24 Clinical trials Not Allowed) · The funder's estimated date (Jul 15, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
- Forecast to Renew the Notice of Funding Opportunity Announcement for the Multiple Chronic Disease Research Centers · The funder's estimated date (Jul 25, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
- Genomic Variant Interactions With Other Variants Or The Environment (UM1 Clinical Trials Not Allowed) · The funder's estimated date (Aug 22, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
- Forecast to Publish a Funding Opportunity Announcement for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Administrative Resource (Collaborative U24 - Clinical Trials not allowed) · The funder's estimated date (Sep 30, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
- Forecast to Publish a Funding Opportunity Announcement for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Research Resource (Collaborative U24 - Clinical Trials not allowed) · The funder's estimated date (Sep 30, 2025) has passed. Check the official notice Estimate, not confirmed by the funder
About this grant
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, from the official notice
Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Your schedule, working back from the deadline
- Oct7
Check that your SAM.gov registration is active (or start it now)
Grants.gov: allow up to 10 business days for SAM registration, weeks or months if information isn't verified. It must be renewed every year. Grants.gov - Sep24
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - Oct8
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - Oct13
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Oct15
Deadline
From the funder.
Save this grant to put these dates in My grants and your private calendar.
Who in Tennessee has won this program
26 awards to Tennessee groups in 2 counties since 1989. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $14.9M spent that year | 2025 |
| Vanderbilt University | Nashville | $14.8M spent that year | 2025 |
| Vanderbilt University | Nashville, Davidson County | $8.7M | 2001 |
| Vanderbilt University | Nashville, Davidson County | $8.7M | 2006 |
| Vanderbilt University | Nashville, Davidson County | $8.1M | 2005 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $7.4M | 2020 |
| Vanderbilt University | Nashville, Davidson County | $6.8M | 2004 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $6.4M | 2005 |
| Vanderbilt University | Nashville, Davidson County | $5.4M | 2009 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $5.3M | 2020 |
| Vanderbilt University | Nashville, Davidson County | $5M | 2002 |
| Vanderbilt University | Nashville, Davidson County | $4.5M | 1989 |
Source: Federal Audit Clearinghouse, USAspending.gov. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through Tennessee Department of Mental Health and Substance Abuse Services
This federal money also reaches local groups as pass-through grants. In Tennessee, Tennessee Department of Mental Health and Substance Abuse Services passes it on: watch that agency for applications, not the federal agency. 73 pass-through grants on file. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | The Trustees of Princeton University | $1.6M | 2023 |
| Vanderbilt University | Nashville, Davidson County | The Pennsylvania State University | $1.1M | 2026 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Vanderbilt University | $920K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The General Hospital Corporation | $839K | 2026 |
| Vanderbilt University | Nashville, Davidson County | The Pennsylvania State University | $756K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Icahn School of Medicine at Mount Sinai | $734K | 2025 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $560K | 2023 |
| University of Tennessee | Memphis, Shelby County | University of Puerto Rico | $553K | 2026 |
| Vanderbilt University | Nashville | Vumc | $500K spent that year | 2024 |
| Vanderbilt University | Nashville | Vanderbilt University Medical Center | $493K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Icahn School of Medicine at Mount Sinai | $487K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Icahn School of Medicine at Mount Sinai | $462K | 2024 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Mental Health Research Grants
Program number 93.242 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement), project grant, training
How applications are judged
The following consideration will be used in determining projects to be funded: (1) Technical merit of the proposed project as determined by peer review; (2) Availability of funds; and (3) Relevance to program priorities.
Match
None required (federal program listing).