Opportunity Information: Apply for PAR 23 097
The National Institutes of Health (NIH) is offering a discretionary health research grant opportunity titled "Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional)," Funding Opportunity Number PAR-23-097 (CFDA 93.242). The overall goal is to support translational research that clarifies why mood disorders and psychotic disorders can first appear, worsen, or change course during the menopause transition (MT). By focusing on the biology and behavior linked to this life stage, the program is intended to surface clear, testable targets that can later be used to design and refine new or improved treatment and prevention strategies for people experiencing clinically significant psychiatric symptoms during perimenopause and menopause.
The scientific emphasis is on novel, innovative, hypothesis-driven work that connects clinical presentation to underlying mechanisms. NIH is specifically interested in studies that explain neurobiological and behavioral processes associated with depressive symptoms, anxiety, bipolar disorder, schizophrenia-spectrum symptoms, and related mood or psychosis phenomena as ovarian function becomes more variable and reproductive hormones fluctuate. A key theme is moving beyond description and toward mechanistic understanding: applications are expected to articulate how proposed measures and analyses will illuminate mechanisms of action rather than simply document symptom prevalence or correlations.
Within that broader aim, the opportunity highlights several priority areas. One is the real-world overlap of "classic" psychiatric symptoms with menopause-related symptoms such as hot flashes, night sweats, and sleep disturbance, including how those physical symptoms interact with mood, cognition, and daily functioning. Another is the role of reproductive steroids and their changing patterns during the menopause transition, including how hormonal variability may affect brain systems involved in emotion regulation, stress responsivity, reward processing, and psychosis-related pathways. The FOA also encourages careful attention to staging and diagnosis, meaning applicants should consider how mood and psychosis symptoms may differ depending on menopausal stage and how diagnostic clarity can be improved when symptoms of menopause and psychiatric illness occur together. In addition, NIH signals interest in co-occurring psychiatric and menopause symptoms, psychosocial factors common in midlife (for example, stress, caregiving demands, health changes, or social role transitions), and the importance of differential diagnosis so that clinicians and researchers can distinguish between overlapping symptom profiles and identify who is at greatest risk for severe or persistent illness.
Interdisciplinary collaboration is explicitly encouraged. This reflects the reality that understanding psychiatric risk during the menopause transition often requires expertise that spans psychiatry, neuroscience, endocrinology, gynecology, sleep research, epidemiology, biostatistics, and behavioral science. Competitive applications will typically show a coherent team science plan and an integrated approach that links biological measures (such as hormonal dynamics or neural circuitry) with behavioral and clinical outcomes.
The mechanism is an NIH R01 research project grant, with "Clinical Trial Optional" status, meaning applicants may propose studies that include a clinical trial if it fits the aims, but a clinical trial is not required. Review is expected to prioritize applications that are comprehensive in their treatment of neurobiology and mechanisms of action underlying mood and psychosis symptoms during the menopause transition, and that are clearly hypothesis-driven with strong rationale and well-matched methods.
Eligibility is broad and includes many common applicant types such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; non-federally recognized tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Historically Black Colleges and Universities (HBCUs); Hispanic-serving Institutions; Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; regional organizations; and non-U.S. entities (foreign organizations). The original closing date listed for the opportunity is 2024-11-05. The award ceiling and expected number of awards are not specified in the provided source information.Apply for PAR 23 097
- 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.
- This funding opportunity was created on 2023-01-06.
- Applicants must submit their applications by 2024-11-05. (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.
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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity?
This is a National Institutes of Health (NIH) discretionary health research grant opportunity titled "Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional)". The Funding Opportunity Number is PAR-23-097, and the CFDA listing provided is 93.242.
What is the main purpose of PAR-23-097?
The overall goal is to support translational research that clarifies why mood disorders and psychotic disorders can first appear, worsen, or change course during the menopause transition (MT). The program aims to identify clear, testable targets that can later inform new or improved treatment and prevention strategies for people experiencing clinically significant psychiatric symptoms during perimenopause and menopause.
What types of psychiatric symptoms or conditions are emphasized?
NIH highlights research on neurobiological and behavioral processes related to:
- Depressive symptoms
- Anxiety
- Bipolar disorder
- Schizophrenia-spectrum symptoms
- Related mood or psychosis phenomena
The emphasis is on how these symptoms relate to ovarian function variability and fluctuating reproductive hormones during the menopause transition.
What does NIH mean by "mechanistic" and "hypothesis-driven" research in this FOA?
The opportunity prioritizes novel, innovative, hypothesis-driven studies that connect clinical presentation to underlying mechanisms. Applications are expected to explain how proposed measures and analyses will illuminate mechanisms of action, rather than primarily documenting symptom prevalence, descriptive patterns, or correlations.
Is this FOA focused on basic science, clinical research, or both?
Based on the description provided, the intent is translational, meaning it supports work linking biology and behavior to clinically relevant outcomes during the menopause transition, with the aim of generating actionable targets for future treatment and prevention development.
What are the priority research areas highlighted in this opportunity?
The provided summary highlights several areas NIH is especially interested in, including:
- The overlap of "classic" psychiatric symptoms with menopause-related symptoms (for example, hot flashes, night sweats, and sleep disturbance)
- How physical menopause symptoms interact with mood, cognition, and daily functioning
- The role of reproductive steroids and changing hormonal patterns during the menopause transition
- How hormonal variability may affect brain systems involved in emotion regulation, stress responsivity, reward processing, and psychosis-related pathways
- Staging and diagnosis across menopausal stages, including improving diagnostic clarity when menopause symptoms and psychiatric symptoms occur together
- Co-occurring psychiatric and menopause symptoms
- Psychosocial factors common in midlife (for example, stress, caregiving demands, health changes, and social role transitions)
- Differential diagnosis to distinguish overlapping symptom profiles and identify who is at greatest risk for severe or persistent illness
Why does the FOA emphasize menopause-related symptoms like hot flashes, night sweats, and sleep problems?
The opportunity notes the real-world overlap between menopause-related symptoms (such as hot flashes, night sweats, and sleep disturbance) and psychiatric symptoms, and encourages research that explains how these physical symptoms may interact with mood, cognition, and daily functioning during the menopause transition.
How important is menopausal staging and diagnostic clarity in proposed studies?
Staging and diagnosis are explicitly emphasized. The FOA encourages applicants to consider how mood and psychosis symptoms may differ depending on menopausal stage, and to address the challenge of diagnostic clarity when menopause symptoms and psychiatric illness symptoms occur together.
Does NIH encourage research on psychosocial factors in midlife?
Yes. The opportunity signals interest in psychosocial factors common in midlife, including examples such as stress, caregiving demands, health changes, and social role transitions, particularly as they relate to psychiatric symptoms and risk during the menopause transition.
What is meant by "interdisciplinary collaboration" in this FOA?
The FOA explicitly encourages interdisciplinary collaboration because understanding psychiatric risk during the menopause transition often requires expertise spanning multiple fields. The provided examples include psychiatry, neuroscience, endocrinology, gynecology, sleep research, epidemiology, biostatistics, and behavioral science.
What kind of project team is NIH looking for?
Competitive applications are expected to reflect a coherent team science plan and an integrated approach that links biological measures (for example, hormonal dynamics or neural circuitry) with behavioral and clinical outcomes. The FOA description suggests that well-integrated cross-disciplinary expertise is valued.
What grant mechanism is used for this program?
This opportunity uses the NIH R01 research project grant mechanism.
What does "Clinical Trial Optional" mean here?
"Clinical Trial Optional" means applicants may propose studies that include a clinical trial if it fits the aims, but a clinical trial is not required to apply under this FOA.
What does NIH say reviewers will prioritize?
Review is expected to prioritize applications that are comprehensive in their treatment of neurobiology and mechanisms of action underlying mood and psychosis symptoms during the menopause transition, and that are clearly hypothesis-driven with strong rationale and well-matched methods.
Who is eligible to apply?
Eligibility is broad. The provided information lists many eligible applicant types, including:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Non-federally recognized tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (outside higher education)
- For-profit organizations (other than small businesses)
- Small businesses
- Other eligible entities
Are institutions serving specific populations explicitly included as eligible?
Yes. The FOA description calls out additional eligible applicant categories, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving Institutions
- Tribally Controlled Colleges and Universities (TCCUs)
Are federal agencies and community-based organizations eligible?
Yes. The description includes eligible federal agencies and also lists faith-based or community-based organizations among eligible applicants.
Can non-U.S. organizations apply?
Yes. The eligibility list includes non-U.S. entities (foreign organizations).
Are U.S. territories or regional organizations eligible?
Yes. The FOA description includes U.S. territories or possessions and regional organizations as eligible applicant categories.
What is the application deadline shown in the provided information?
The original closing date listed in the provided source information is 2024-11-05.
How much funding is available per award (award ceiling)?
The award ceiling is not specified in the provided source information.
How many awards does NIH expect to make?
The expected number of awards is not specified in the provided source information.
What kinds of outcomes is NIH ultimately trying to enable through this research?
The program is intended to surface clear, testable targets grounded in menopause-transition biology and behavior, so that future work can design and refine new or improved treatment and prevention strategies for clinically significant mood and psychosis symptoms during perimenopause and menopause.
What kinds of studies might be less aligned with the FOA as described?
Based on the description provided, studies that primarily remain descriptive (for example, focusing mainly on prevalence, symptom counts, or simple correlations) without a clear plan to illuminate mechanisms of action may be less aligned than studies that explicitly test mechanistic hypotheses linking clinical presentation to neurobiological and behavioral processes.
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