Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional)
Can you apply?
This grant is for biomedical and behavioral research on mood and psychosis symptoms during the menopause transition. The NIH R01 mechanism supports independent research projects led by experienced investigators. Eligible applicants include research institutions, universities, hospitals, and other public and private organizations, as well as individual scientists with appropriate credentials and institutional affiliation. Domestic and international institutions may apply, though U.S. citizenship or permanent residency is typically required for principal investigators. The research must be conducted in the United States or its territories. This grant supports hypothesis-driven clinical trials and observational studies investigating the relationship between menopause transition and psychiatric symptoms, with emphasis on rigorous study design and potential for clinical application.
This grant is for biomedical and behavioral research on mood and psychosis symptoms during the menopause transition. The NIH R01 mechanism supports independent research projects led by experienced investigators. Eligible applicants include research institutions, universities, hospitals, and other public and private organizations, as well as individual scientists with appropriate credentials and institutional affiliation. Domestic and international institutions may apply, though U.S. citizenship or permanent residency is typically required for principal investigators. The research must be conducted in the United States or its territories. This grant supports hypothesis-driven clinical trials and observational studies investigating the relationship between menopause transition and psychiatric symptoms, with emphasis on rigorous study design and potential for clinical application.
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
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for biomedical and behavioral research on mood and psychosis symptoms during the menopause transition. The NIH R01 mechanism supports independent research projects led by experienced investigators. Eligible applicants include research institutions, universities, hospitals, and other public and private organizations, as well as individual scientists with appropriate credentials and institutional affiliation. Domestic and international institutions may apply, though U.S. citizenship or permanent residency is typically required for principal investigators. The research must be conducted in the United States or its territories. This grant supports hypothesis-driven clinical trials and observational studies investigating the relationship between menopause transition and psychiatric symptoms, with emphasis on rigorous study design and potential for clinical application.
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and supporting checklist
- Project narrative (typically 12-15 pages) describing specific aims, background, research design, methods, and significance
- Detailed budget and budget justification for Year 1 and cumulative budget narrative for out-years
- Biographical sketches (2-page NIH format) for PI and key personnel
- Institutional authorization letter and institutional commitment
- Literature Cited section
- Research Design and Methods section with power calculations and statistical plans
- Data and Safety Monitoring Plan (required for clinical trials)
- Letters of support from key collaborators or partner institutions
- Human Subjects Protection documentation (IRB approval or protocol)
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 can serve as a Principal Investigator on this R01?
The PI must have a doctoral degree (Ph.D., M.D., D.O., D.D.S., D.V.M., or equivalent) and be affiliated with an eligible institution. Early-career and established investigators are encouraged to apply.
What is the typical funding range for this R01?
NIH R01 awards typically range from $250,000 to $750,000 per year in direct costs, depending on the project scope and complexity. Your institution's facilities and administrative (F&A) rate is also covered.
What activities and research approaches are supported?
This grant supports prospective clinical studies, biomarker research, mechanistic investigations, and clinical trials examining psychiatric symptoms during menopause transition. Mixed-methods, longitudinal, and intervention studies are all appropriate.
How competitive is this funding opportunity?
R01 mechanisms are highly competitive, with typical success rates around 15-25% across NIH. Strong preliminary data, clear innovation, and experienced research teams significantly improve competitiveness.
When is the next deadline and how much time do I have to apply?
The next deadline is January 7, 2028, with applications typically due by 5:00 PM ET. You should plan 3-4 months for a thorough competitive application.
💡 Tips for applicants
- Establish strong preliminary data demonstrating feasibility of your clinical trial or observational study design; reviewers expect clear proof-of-concept before funding a larger investigation.
- Address health equity and diversity explicitly: the NIH prioritizes applications that include diverse participant populations and discuss how menopause symptoms may differ across racial, ethnic, and socioeconomic groups.
- Build a multidisciplinary research team including gynecologists, psychiatrists, or reproductive endocrinologists alongside your primary research expertise to strengthen scientific credibility and clinical relevance.
- Detail your recruitment and retention strategy upfront, particularly for long-term longitudinal studies; include realistic timelines, partnerships with women's health clinics, and methods to reduce attrition.
- Clearly specify your primary and secondary outcomes, sample size justification, and statistical analysis plan early in your proposal; vague or underpowered designs are common reasons for reviewer critique.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data or evidence of feasibility, leaving reviewers uncertain whether the research team can execute the proposed clinical trial. Another frequent issue is insufficient attention to potential confounders (hormonal status, antipsychotic exposure, substance use) and failure to justify why the menopause transition itself—rather than aging or other factors—is driving psychiatric symptoms. Weak recruitment plans and underestimation of the challenges in retaining women through a multi-year longitudinal study also commonly lead to low priority scores.
Similar grants
- OPEN 27-0343-10 FFY27 Local Agency General Non-Enforcement — Illinois Department of Transportation
- ROLLING Annual Agency Threshold Application Applicants for Funding Start Here — Texas City of Austin - Austin Public Health
- CLOSED Virginia’s Black Indigenous and People of Color (BIPOC) Grant – FY26 — Virginia The Virginia Department of Historic Resources
- ROLLING RTAP Grant Program (Rolling) — Virginia Department of Rail and Public Transportation
- ROLLING Rail Industrial Access Grant (RIA) — Virginia Department of Rail and Public Transportation