The Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders funding opportunity (PAR-25-179), issued by the National Institutes of Health (NIH), supports clinical trials that test the efficacy of therapeutic and preventive interventions for mental disorders in adults and children. These trials aim to address unmet therapeutic needs and are designed under the NIMH's experimental therapeutics framework, which emphasizes understanding the mechanisms of action and disease processes that contribute to therapeutic changes.
Eligible applicants include public and private institutions of higher education, nonprofits, for-profit organizations, small businesses, state and local governments, Native American tribal entities, and community-based organizations. International entities and regional organizations are also eligible. The opportunity encourages submissions from diverse applicants, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and other institutions serving underrepresented populations.
The program supports confirmatory trials of interventions designed to advance the understanding of mental health treatments and prevention strategies. Applications must focus on interventions that align with NIMH priorities and demonstrate potential to address significant mental health challenges. Proposals should include hypotheses based on prior pilot data and detail the intervention’s mechanisms of action. The trials must be adequately powered to answer primary research questions definitively.
There is no specified ceiling or floor for award amounts, and cost-sharing is not required. Applications are accepted on a rolling basis, with the final submission deadline on October 15, 2027. Successful projects will provide actionable insights into therapeutic mechanisms and inform future mental health interventions.
This funding opportunity is critical for advancing the scientific understanding of mental health treatments and improving outcomes for individuals with mental disorders. For more details, applicants can access the full NOFO or contact NIH Grants Information at grantsinfo@nih.gov.
