Mood and Psychosis Symptoms during the Menopause Transition (R21 Clinical Trial Optional) | PAR 23 102

Opportunity Information: Apply for PAR 23 102

Mood and Psychosis Symptoms during the Menopause Transition (R21 Clinical Trial Optional) is an NIH discretionary grant opportunity (Funding Opportunity Number PAR 23 102; CFDA 93.242) designed to push translational research forward on why mood and psychotic disorders can first appear, worsen, or change course during the menopause transition. The scientific emphasis is on generating a clearer, mechanism-based understanding of perimenopausal depression, anxiety disorders such as generalized anxiety disorder, and more severe conditions including bipolar disorder and schizophrenia in the context of the shifting hormonal and physiological landscape of midlife. A central goal is to identify actionable targets that could inform the future development of new or improved treatment interventions, rather than simply documenting symptom patterns.

The FOA specifically calls for novel and innovative research that bridges clinical observations with underlying neurobiological and behavioral mechanisms. In practical terms, applicants are expected to propose hypothesis-driven projects that can explain how and why symptoms emerge or intensify during the menopause transition, and to connect those explanations to measurable pathways (for example, neural circuits, endocrine changes, stress-response systems, sleep and circadian disruption, or other biologically plausible mechanisms). Because it is an R21 mechanism, the opportunity is well aligned with early-stage, exploratory, and high-impact ideas that may lead to larger subsequent studies, and it allows clinical trials but does not require them (hence "clinical trial optional").

Priority topics include the ways classic depressive symptoms overlap and interact with hallmark menopause-related symptoms such as hot flashes, night sweats, and sleep disturbance, as well as the psychological burdens that can cluster during midlife. The FOA also highlights the role of reproductive steroids and their fluctuations in regulating mood and behavior during the menopause transition, encouraging studies that treat hormonal dynamics as more than background context and instead evaluate them as potential drivers, moderators, or biomarkers of psychiatric risk. Another key interest is improving diagnostic clarity by anchoring mood and psychosis symptoms to menopausal stage, which can help distinguish menopause-transition-related symptom changes from other psychiatric presentations, medical causes, or life-stress-related shifts that commonly occur in the same age range.

In addition, the opportunity encourages research that examines co-occurring psychiatric symptoms alongside menopause symptoms, rather than studying them in isolation. This includes work that accounts for psychosocial factors common in midlife (for example, caregiving demands, occupational stress, relationship transitions, health changes, or cumulative life stress) and uses that context to refine differential diagnosis and mechanistic hypotheses. The FOA also explicitly encourages interdisciplinary collaboration, reflecting the expectation that strong applications may integrate perspectives and methods from psychiatry, neuroscience, endocrinology, gynecology, sleep research, epidemiology, behavioral science, and related fields.

From a review standpoint, the FOA signals that applications will be judged heavily on the strength and completeness of the proposed neurobiology and mechanism-of-action rationale, as well as on clear, testable hypotheses. In other words, proposals that simply describe prevalence, correlations, or broad associations without a coherent mechanistic framework are less aligned with the stated priorities than proposals that articulate specific pathways, specify how those pathways will be measured, and explain how the results could reveal targets for future intervention development.

Eligibility is broad. In addition to typical academic, nonprofit, and governmental applicants, eligible organizations include state, county, city, and special district governments; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses) and small businesses; and nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education, where applicable). The FOA also calls out 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, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. entities (foreign organizations) and regional organizations. The listed agency is the National Institutes of Health, and the opportunity’s original closing date is 2025-01-07.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mood and Psychosis Symptoms during the Menopause Transition (R21 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 2023-01-13.
• Applicants must submit their applications by 2025-01-07. (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 PAR 23 102

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