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Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)

ID: RFA-MH-25-190 • Type: Posted


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.


Category of Funding
Funding Instruments
Cooperative Agreement
Grant Category
Cost Sharing / Matching Requirement
On 4/3/24 the National Institutes of Health posted grant opportunity RFA-MH-25-190 for Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional). The grant will be issued under grant program 93.242 Mental Health Research Grants.


Posted Date
April 3, 2024, 12:00 a.m. EDT
Closing Date
Oct. 18, 2024, 12:00 a.m. EDT Due in 181 Days
Last Updated
April 3, 2024, 2:24 p.m. EDT
Archive Date
Nov. 23, 2024


Eligible Applicants
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
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Private institutions of higher education
Public and State controlled institutions of higher education
Special district governments
State governments
Independent school districts
For profit organizations other than small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
City or township governments
Small businesses
Additional Info
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.


National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information


Posted documents for RFA-MH-25-190

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