This grant from the Mental Health Department is for developing and validating predictive tools and biomarkers to inform personalized treatment selection for depression. This phased (UG3/UH3) program supports multi-disciplinary teams. The initial UG3 phase focuses on identifying potential tools or biomarkers to predict differential patient response to existing depression treatments, utilizing secondary data analysis, real-world data, or small pilot studies. The subsequent UH3 phase involves conducting independent, prospective clinical trials to validate the utility of these tools/biomarkers for predicting differential treatment outcomes. The overall goal is to rigorously test various tools and biomarkers, halting the development of underperforming ones, with the ultimate aim of integrating successful tools into clinical practice for enhanced decision-making in depression care.
Opportunity ID: 353382
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-25-190 |
| Funding Opportunity Title: | Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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: | Apr 03, 2024 |
| Last Updated Date: | Apr 03, 2024 |
| Original Closing Date for Applications: | Oct 18, 2024 |
| Current Closing Date for Applications: | Oct 18, 2024 |
| Archive Date: | Nov 23, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Private institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses County governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education |
| 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: | The purpose of this phased Notice of Funding Opportunity (NOFO) is to create a pipeline to accelerate the development and early validation of predictive tools and/or biomarkers to inform individual-level treatment selection among two or more existing therapeutics for depression. This phased inter-agency program will be milestone-based and provide support from multi-disciplinary teams to address scientific, technical, clinical, regulatory, and commercialization requirements. In the first phase (UG3), investigators are expected to identify potential tools and/or biomarker(s) that can predict whether a patient will differentially respond to one well-established depression treatment versus another. This could be accomplished using secondary analysis of data from completed clinical trials or using real-world clinical data, or by conducting small, efficient pilot feasibility studies to assess promising new tools or biomarkers to predict individual treatment response to a specific therapeutic for depression. In the second phase (UH3), investigators will conduct independent, prospective clinical trials to initially validate the utility of the tool/biomarker for predicting differential response to established treatments for depression. The overall goal of this NOFO is to support the testing of various tools/biomarkers as predictors of response to well-established depression treatments and halt the development of those tools that do not meet sufficient performance characteristics to justify further testing. Ultimately, tools that are successful in early-stage studies could be further evaluated for future use in decision-making in clinical practice settings. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-25-190.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 353382 Full Announcement-RFA-MH-25-190 -> RFA-MH-25-190-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-H | Use for due dates on or after January 25, 2023 | PKG00285724 | Sep 18, 2024 | Oct 18, 2024 | View |
Package 1
Mandatory forms
353382 RR_SF424_5_0-5.0.pdf
353382 PHS398_CoverPageSupplement_5_0-5.0.pdf
353382 RR_OtherProjectInfo_1_4-1.4.pdf
353382 PerformanceSite_4_0-4.0.pdf
353382 RR_KeyPersonExpanded_4_0-4.0.pdf
353382 RR_Budget10_3_0-3.0.pdf
353382 PHS398_ResearchPlan_5_0-5.0.pdf
353382 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353382 RR_SubawardBudget10_30_3_0-3.0.pdf
353382 PHS_AssignmentRequestForm_3_0-3.0.pdf
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