Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional) | PAR 25 281

Opportunity Information: Apply for PAR 25 281

Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional), funding opportunity number PAR 25-281, is an NIH discretionary grant program designed to push translational research forward on a problem that is often under-characterized in midlife health: why mood symptoms and, in some cases, psychosis-related symptoms can newly appear or worsen during the menopause transition. The central goal is to generate mechanistic, hypothesis-driven evidence that clarifies what is happening biologically and behaviorally during perimenopause and the broader menopause transition, so the field can identify concrete targets for the future development of better, more tailored interventions.

The NOFO is specifically interested in research that helps explain the emergence, recurrence, or intensification of conditions such as perimenopausal depression, generalized anxiety disorder, bipolar disorder, and schizophrenia-spectrum illnesses in the context of the menopause transition. A major emphasis is on understanding mechanisms rather than simply documenting that symptoms occur. Applicants are encouraged to propose innovative translational approaches that connect clinical phenomena to underlying neurobiology and behavioral processes, for example by linking symptom changes to measurable changes in brain systems, stress and arousal pathways, sleep and circadian biology, or other biologically grounded pathways that could plausibly be modified with treatment.

A key theme throughout the opportunity is the interaction between classic psychiatric symptoms and menopause-related symptoms and experiences. The announcement highlights interest in depressive symptoms that occur alongside common menopause symptoms such as hot flashes, night sweats, and sleep disturbance, as well as the psychological and functional challenges that can accompany midlife. Another explicit priority is the role of reproductive steroids in regulating mood and behavior during the menopause transition, reflecting the program’s interest in how fluctuating and declining hormones may shape risk, symptom profiles, and trajectories for different disorders and symptom domains. The NOFO also calls attention to the importance of determining how mood and psychosis symptoms should be diagnosed or characterized at different menopausal stages, how psychiatric and menopause symptoms co-occur and potentially reinforce each other, and how psychosocial factors common in midlife might contribute to onset, worsening, or differential presentation. Differential diagnosis is included as an area of interest, signaling that strong applications should grapple with how to distinguish overlapping symptom constellations and competing clinical explanations.

From a review perspective, the announcement signals that proposals will be judged heavily on the strength and completeness of their mechanistic rationale and the clarity of the neurobiology or mechanisms-of-action being tested. In practice, this means reviewers will be looking for well-justified hypotheses, rigorous approaches that can actually test those hypotheses, and an integrated plan that connects menopause transition biology and timing with psychiatric outcomes. The NOFO also encourages interdisciplinary collaboration, which fits the reality that answering these questions often requires clinical psychiatry, women’s health, endocrinology, neuroscience, sleep research, and behavioral science working together rather than in silos.

The mechanism is an R01 (research project grant), and clinical trials are optional, allowing applicants to propose either observational or interventional studies depending on what best tests the proposed mechanism. The opportunity falls under NIH health-related funding activity categories and is associated with CFDA numbers 93.242 and 93.313. The program is open to a wide range of applicant organizations, including state and local governments; public and private institutions of higher education; independent school districts; special district governments; Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized governments); public housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The NOFO also explicitly notes additional eligible applicant types such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities.

The opportunity was created on 2024-11-22 and lists an original closing date of 2028-01-07. While an award ceiling is not specified in the provided source details and the expected number of awards is not listed, the overall intent is clear: fund rigorous, mechanistically informative translational projects that can explain vulnerability to mood and psychosis symptoms during the menopause transition and lay the groundwork for new or improved interventions that are better matched to this life stage.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mood and Psychosis Symptoms during the Menopause Transition (R01 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, 93.313.
• This funding opportunity was created on 2024-11-22.
• Applicants must submit their applications by 2028-01-07.
• 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 25 281

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