The funding opportunity "Schizophrenia and Related Disorders During Mid- to Late-Life (R01 Clinical Trial Optional)" supports research to better understand the development, progression, and outcomes of schizophrenia and related psychotic disorders in individuals aged 35 and older. The initiative emphasizes identifying neurobiological, behavioral, psychosocial, and environmental mechanisms that contribute to the emergence and trajectory of these disorders in mid- to late-life. Projects are encouraged to identify new targets for prevention and treatment and to enhance existing healthcare and community services to better meet the needs of affected individuals.

This program focuses on schizophrenia spectrum and nonaffective psychotic disorders, as well as bipolar disorder with psychosis, in mid- to late-life. Research areas of interest include studies on first-episode psychosis in later life, mechanisms linking these disorders to increased dementia risk, and the influence of accelerated biological aging. The initiative encourages projects addressing health disparities and minority populations using an intersectionality framework. Incorporating multidisciplinary approaches and diverse research teams is highly encouraged, including those with lived experience of psychosis.

The funding mechanism supports R01 projects, which may include clinical trials, with budgets appropriate to the project’s scope and a maximum duration of five years. Eligible applicants include higher education institutions, nonprofits, for-profit entities, government entities, and foreign organizations. Research should utilize advanced methodologies, such as high-field neuroimaging and computational models, and align with the NIMH’s Research Domain Criteria (RDoC) framework. Projects must address mechanisms at multiple levels of analysis and integrate findings across biological and psychosocial domains.

Applications must comply with NIH data sharing and rigor requirements, including plans for managing and sharing data through platforms like the NIMH Data Archive (NDA). Proposals must demonstrate statistical and experimental rigor, address comorbidities, and justify study populations. Applications seeking $500,000 or more in direct costs in any year require prior consultation with NIH staff.

The program offers multiple submission deadlines annually, beginning on February 5, 2025, with an expiration date of September 8, 2026. Review criteria include significance, innovation, approach, and investigator expertise, with additional considerations for human subjects, vertebrate animals, and data sharing plans. Applicants are encouraged to contact NIMH staff to ensure alignment with program priorities. Outcomes will be assessed based on relevance to program goals, scientific merit, and budget considerations.