Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional) (353382)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Sep 18, 2024 (Letter of inquiry)

Later deadlines: Oct 18, 2024 (Full proposal)

Grant amount: Up to US $8,500,000

Fields of work: Mental Health & Psychiatric Diseases Biomedical informatics Medical Technology & Devices

Applicant type: Nonprofit, Government Entity, Indigenous Group, For-Profit Business

Funding uses: Research

Location of project: Anywhere in the world

Location of residency: Anywhere in the world

Overview:

NOTE: All applications are due by 5:00 PM local time of applicant organization.

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.

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed April 07, 2024 and last updated April 07, 2024