Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional) | RFA MH 24 120

Opportunity Information: Apply for RFA MH 24 120

Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity (RFA-MH-24-120; CFDA 93.242) designed to speed up the creation and validation of practical biomarkers or decision tools that can help clinicians choose the right existing depression treatment for an individual patient. The central idea is not to invent brand-new treatments, but to improve treatment selection by predicting which of two or more established options is most likely to work for a given person. The program emphasizes tools that are sensitive enough to pick up meaningful differences in likely response at the individual level, with the end goal of improving outcomes compared to how treatment is typically chosen today (clinician judgment, patient preference, trial-and-error, or standard guidelines).

The opportunity uses a phased cooperative agreement structure (UG3/UH3; the description also references similar phased mechanisms like R61/R33), which means projects are expected to move through a structured development pipeline with clear milestones and NIH involvement typical of cooperative agreements. Phase 1 can last up to two years and is meant to "de-risk" the proposed biomarker or tool. In practice, that means applicants should use efficient early-stage approaches such as retrospective secondary analyses of data from completed depression clinical trials and/or fast, nimble pilot studies that can quickly show whether the signal is strong enough to justify a larger prospective trial. Phase 1 is explicitly tied to objective go/no-go decision points, with examples including futility analyses, receiver operating characteristic (ROC) curves, and/or effect size benchmarks. The expectation is that Phase 1 will not just generate interesting correlations, but will provide quantitative evidence that the tool has plausible clinical utility for guiding treatment selection before the program invests in a larger, more expensive trial.

Phase 2 can last up to five years and focuses on prospective, large-scale testing of the biomarker or tool in biomarker/tool-stratified clinical trials. This is where the tool is tested in a real-world decision context: participants are assigned treatment either using the biomarker/tool-guided strategy or using standard-of-care decision-making as the comparison condition. The "control" approach is described as clinician/patient treatment assignment (what typically happens in practice), while the "test" is assignment guided by the new biomarker or tool. The key performance bar is therefore practical and patient-centered: the tool should help a treatment-selection strategy outperform usual decision-making, rather than merely demonstrating statistical associations. Because the clinical trial component is described as optional under UG3/UH3, the FOA is structured to accommodate projects that may or may not include a clinical trial, but the overall narrative of Phase 2 clearly prioritizes prospective validation in a clinical-trial framework when appropriate.

From an eligibility standpoint, the FOA is broadly open and intentionally inclusive. Eligible applicants include a wide range of U.S. governmental entities (state, county, city/township governments; special districts; independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. It also explicitly welcomes applications from Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), public housing authorities/Indian housing authorities, and additional categories labeled as "Other" in the listing. The announcement further highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This breadth signals an intent to support tools that can be developed and tested across diverse settings and populations, which matters for depression where treatment response and access to care can vary significantly.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument, indicating substantial NIH programmatic engagement during the project. The original closing date listed is April 3, 2024, and the funding listing does not specify an award ceiling or expected number of awards in the provided excerpt. Overall, the FOA is aimed at moving the field toward precision mental health for depression by funding a stepwise process: first proving that a proposed biomarker/tool has a strong enough predictive signal to be clinically useful, and then rigorously testing whether using it to guide treatment selection actually improves patient outcomes compared to standard care.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2023-06-02.
• Applicants must submit their applications by 2024-04-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA MH 24 120

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