This NIMH grant is for the early stage testing of pharmacologic or device-based interventions targeting mental disorders. Aligned with NIMH’s experimental therapeutics approach, the grant emphasizes evaluating an intervention’s clinical effect while simultaneously generating critical information about underlying disorder mechanisms or intervention responses. It particularly encourages novel pharmacologic agents and device-based solutions within NIMH’s Clinical Trial Pipeline. Applicants must design protocols that rigorously test the intervention’s presumed mechanism of action, aiming to demonstrate how target modulation leads to dose-dependent neurophysiological, clinical, or behavioral effects. This grant ensures that early testing yields meaningful insights into both efficacy and fundamental biological processes related to mental health.
Opportunity ID: 357433
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-184 |
| Funding Opportunity Title: | Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 27, 2024 |
| Last Updated Date: | Nov 27, 2024 |
| Original Closing Date for Applications: | Oct 15, 2027 |
| Current Closing Date for Applications: | Oct 15, 2027 |
| Archive Date: | Nov 20, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts State governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education Public housing authorities/Indian housing authorities Special district governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-184.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357433 Full Announcement-PAR-25-184 -> PAR-25-184-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289193 | Jan 14, 2025 | Oct 15, 2027 | View |
Package 1
Mandatory forms
357433 RR_SF424_5_0-5.0.pdf
357433 PHS398_CoverPageSupplement_5_0-5.0.pdf
357433 RR_OtherProjectInfo_1_4-1.4.pdf
357433 PerformanceSite_4_0-4.0.pdf
357433 RR_KeyPersonExpanded_4_0-4.0.pdf
357433 RR_Budget10_3_0-3.0.pdf
357433 PHS398_ResearchPlan_5_0-5.0.pdf
357433 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357433 RR_SubawardBudget10_30_3_0-3.0.pdf
357433 PHS_AssignmentRequestForm_4_0-4.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
