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

Background
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.

Grant Details
The first phase (UG3) requires investigators 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.

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.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government agencies, foreign organizations, and others. Multiple principal investigators are required in this NOFO. Applicants must complete and maintain several registrations such as System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code, Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.

Period of Performance
The UG3 phase will support preparatory research for one to two years. Based on milestone progress, a limited number of projects will proceed to the UH3 phase for the remainder of the award period.
The UH3 phase will include optimization and initial clinical validation studies of the predictive tool.

Grant Value
$5,000,000 in FY 2025 is intended to fund up to 10 awards. Application budgets are limited to $500,000 in direct costs per year for the UG3 phase and up to $1,500,000 in direct costs per year of the UH3 phase.