Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required) | PAR 25 179

Opportunity Information: Apply for PAR 25 179

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is offering an R01 grant opportunity (Funding Opportunity Number PAR-25-179) to support confirmatory efficacy clinical trials for interventions aimed at mental disorders in both adults and children. This program sits within NIMH's clinical trials pipeline and is specifically intended to move interventions beyond early testing into more definitive, confirmatory studies that can more clearly establish whether an intervention works under well-controlled conditions. The focus is on addressing unmet therapeutic needs in mental health, meaning applicants should be targeting gaps where current treatments are insufficient, unavailable, or do not work well for certain populations or settings.

A central feature of this opportunity is NIMH's emphasis on the experimental therapeutics approach. In practical terms, NIMH is not only looking for trials that measure whether symptoms improve, but for studies that are designed to test a clear, scientifically grounded mechanism of action. Applicants are expected to identify an intervention target (for example, a cognitive, behavioral, neural circuit, physiological, or social process linked to the disorder) and then design the trial in a way that can determine whether the intervention actually engages that target and whether target engagement is meaningfully related to clinical improvement. This means the trial should generate knowledge about the relationship between underlying disease processes and how the intervention produces change, rather than treating the intervention as a "black box."

Although the title references both non-pharmacological and pharmacological interventions, the provided description emphasizes non-pharmacological therapeutic and preventive interventions. In this context, non-pharmacological typically includes approaches such as psychotherapies, behavioral interventions, digital or technology-based interventions, neurostimulation or device-based strategies, services and systems interventions, caregiver- or family-based programs, and preventive interventions designed to reduce risk or delay onset. Regardless of modality, the key expectation is that the study is a confirmatory efficacy clinical trial and that it aligns with the experimental therapeutics framework by measuring mechanism-relevant outcomes alongside clinical endpoints.

The funding instrument is an NIH research project grant (R01), and a clinical trial is required under this notice. The opportunity is categorized as discretionary health funding (CFDA 93.242). The listing does not specify an award ceiling or the expected number of awards in the provided text, so applicants would need to consult the full notice and NIH budgeting policies for detailed limits and expectations. The original closing date is listed as October 15, 2027, indicating a multi-year window during which applications may be accepted on relevant due dates, consistent with how many NIH program announcements operate.

Eligibility is broad and includes many organization types that commonly apply for NIH funding. Eligible applicants include state, county, city or township governments, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (including small businesses and other for-profits that are not small businesses); and a general "other" category that can capture additional eligible entities depending on NIH rules. The opportunity also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This broad eligibility reflects NIMH's interest in supporting research that can be carried out across diverse settings and populations, including organizations with strong ties to communities that are often underserved or underrepresented in clinical research.

Overall, this grant opportunity is aimed at investigators and institutions ready to run rigorous, mechanism-informed confirmatory efficacy trials for mental health interventions. Competitive applications will typically be those that present a strong scientific rationale for the intervention and its target, use a clinical trial design capable of producing clear efficacy conclusions, incorporate measures that demonstrate target engagement and link it to clinical outcomes, and address important unmet needs in mental health care for children, adolescents, and/or adults.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)" 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 2024-11-26.
• Applicants must submit their applications by 2027-10-15.
• 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 PAR 25 179

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