Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional)

The National Institute of Mental Health (NIMH) invites applications for mechanistic and translational research on mood and psychosis symptoms during the menopausal transition under the R01 mechanism. The funding opportunity supports studies advancing understanding of neurobiological and behavioral mechanisms underlying mood disruption, emotional dysregulation, and psychosis during this critical period. Applications are also encouraged to identify novel targets for future intervention or prevention strategies. Proposals may include mechanistic clinical trials but must align with the mission of the NIMH and Office of Research on Women’s Health (ORWH). High-risk, high-reward studies without preliminary data should apply under the companion R21 mechanism. The menopausal transition, defined as the period from onset of menstrual cycle changes to early post-menopause, represents a high-risk window for mood and psychotic disorders. Research shows that women face increased rates of major depressive disorder and psychosis during this time, influenced by factors such as prior mental health history and hormonal changes. The program encourages a dimensional, Research Domain Criteria (RDoC)-aligned approach to studying these phenomena, integrating multiple levels of analysis, including neurobiology, behavior, and self-report. Proposals that adopt intersectionality frameworks or employ advanced technologies such as high-field magnetic resonance imaging (MRI) are especially encouraged. Eligible research should target populations transitioning through menopause and emphasize mechanistic studies that address neurobiological or behavioral processes. Comparative studies using groups such as men or women who underwent surgical menopause may be included if scientifically justified. Applications are expected to include data-sharing plans, employ robust methodologies, and incorporate assessment measures to validate menopausal status. The scope excludes purely descriptive studies, stand-alone technological development, or animal models. Applications are not budget-capped but must justify requested resources. The maximum project duration is five years. Higher education institutions, nonprofits, for-profit organizations, and eligible foreign entities can apply. Registrations for SAM, eRA Commons, and Grants.gov are mandatory before submission. Applications are due annually in February, June, and October, starting February 5, 2025. Applicants must include detailed research strategies, rigorous methodologies, and plans for data sharing via the NIMH Data Archive (NDA). Key evaluation criteria will include the significance, innovation, and feasibility of the proposed research, as well as the investigator's expertise and the availability of institutional resources. This opportunity addresses significant public health challenges associated with menopause-related mental health risks, aiming to improve understanding and intervention development for affected women. Successful projects will contribute to advancing mental health outcomes and reducing the burden of mood and psychotic disorders in this population.