Mood and Psychosis Symptoms during the Menopause Transition (R21 Clinical Trial Optional)
Can you apply?
This grant is for researchers and research institutions conducting clinical research on mood and psychosis symptoms during the menopause transition. Eligible applicants typically include academic medical centers, research hospitals, freestanding research institutions, and nonprofit organizations with research capacity. The NIH R21 mechanism supports exploratory/developmental research and is available to domestic and foreign institutions, as well as individual researchers (including postdoctoral fellows and graduate students under sponsorship). Research may be conducted domestically or internationally. The grant specifically supports clinical trial research examining psychiatric and mood outcomes in women experiencing the menopause transition, with a focus on generating preliminary data that can support larger future R01 applications.
This grant is for researchers and research institutions conducting clinical research on mood and psychosis symptoms during the menopause transition. Eligible applicants typically include academic medical centers, research hospitals, freestanding research institutions, and nonprofit organizations with research capacity. The NIH R21 mechanism supports exploratory/developmental research and is available to domestic and foreign institutions, as well as individual researchers (including postdoctoral fellows and graduate students under sponsorship). Research may be conducted domestically or internationally. The grant specifically supports clinical trial research examining psychiatric and mood outcomes in women experiencing the menopause transition, with a focus on generating preliminary data that can support larger future R01 applications.
Program description
The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders (e.g., perimenopausal depression (PMD), generalized anxiety disorder, bipolar disorder and schizophrenia) during the menopause transition (MT) in an effort to identity targets for future development of novel treatment interventions. This funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during MT. This funding opportunity also encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during the MT. Aspects of mood and psychosis disorders that are of interest include: classic depressive symptoms in combination with menopause symptoms (e.g., hot flashes, night sweats, sleep disturbance) and psychological challenges, the role of reproductive steroids in the regulation of mood and behavior during the MT, diagnosis of mood and psychosis symptoms at menopausal stage, investigation of co-occurring psychiatric and menopause symptoms, appreciation of psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms and hypothesis-driven work.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for researchers and research institutions conducting clinical research on mood and psychosis symptoms during the menopause transition. Eligible applicants typically include academic medical centers, research hospitals, freestanding research institutions, and nonprofit organizations with research capacity. The NIH R21 mechanism supports exploratory/developmental research and is available to domestic and foreign institutions, as well as individual researchers (including postdoctoral fellows and graduate students under sponsorship). Research may be conducted domestically or internationally. The grant specifically supports clinical trial research examining psychiatric and mood outcomes in women experiencing the menopause transition, with a focus on generating preliminary data that can support larger future R01 applications.
How to apply
Application links
Required documents
- SF-424 (R&R) form (application header)
- Project Narrative (typically 15 pages maximum, including specific aims, background/significance, preliminary data, research design/methods, and study timeline)
- Budget and Budget Justification
- Biographical Sketches for key personnel (NIH format page limit typically 4-5 pages per person)
- Facilities and Administrative Resources description
- Letters of Support from collaborating institutions or clinical sites
- IRB approval letter or evidence of pending IRB review
- Research Strategy (specific aims, significance, innovation, and approach sections)
- Data Management and Quality Assurance plan (particularly important for clinical trials)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who is eligible to apply?
Academic institutions, research hospitals, freestanding research organizations, universities, and nonprofit organizations with demonstrated research infrastructure are eligible. NIH also allows certain individual researchers to apply. Foreign institutions may apply but must comply with additional NIH regulations.
What is the typical funding amount and project period?
R21 awards typically provide $275,000-$450,000 in total costs over 2 years, though clinical trial research may have higher budgets. This mechanism is designed for exploratory/developmental work.
What types of research activities are supported?
Supported activities include clinical research, clinical trials, data collection and analysis, preliminary feasibility studies, and research designed to generate pilot data for future larger-scale grant applications.
When is the deadline?
The deadline for this specific FOA is January 7, 2028. Applications typically close at 5:00 PM EST on the deadline date.
How competitive is this funding mechanism?
R21 awards are moderately competitive. Success rates vary but typically range from 20-30% across NIH institutes. A strong preliminary data section and feasibility demonstration significantly improve competitiveness.
💡 Tips for applicants
- Emphasize preliminary data and evidence of feasibility: R21s are designed for exploratory work, so demonstrate you have strong preliminary findings that justify the proposed research direction.
- Focus on innovation and specificity of the menopause-psychiatry connection: Clearly articulate what gap in knowledge your study fills regarding mood/psychosis during menopause, and why current approaches are insufficient.
- Plan for impact and next steps: Explain how results will lead to larger R01 or other follow-up funding and ultimately improve clinical outcomes for women experiencing menopause-related mood disorders.
- Include realistic timelines and milestones: R21s have a 2-year period; ensure your study design is achievable within this window with clearly defined, measurable outcomes and go/no-go decision points.
- Build a multidisciplinary team: Include psychiatrists, gynecologists, endocrinologists, and/or biostatisticians as appropriate to strengthen credibility and demonstrate comprehensive expertise in both psychiatric and menopausal health.
⚠️ Common mistakes
Many applications fail because they present insufficient preliminary data or lack clear evidence that the research team has already established feasibility. Additionally, researchers often underestimate the clinical and regulatory complexity of conducting a clinical trial with vulnerable populations (post-menopausal women with mood/psychosis), leading to unrealistic timelines and budgets that reviewers view skeptically. Finally, weak justification for why the menopause transition specifically is the right window to study these psychiatric outcomes—rather than generalized mood disorder research—undermines the significance and innovation of the proposal.
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