Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
Grant supports clinical trials testing non-pharmacological interventions for mental disorders in adults and children to address unmet therapeutic needs.
Funder: National Institutes of Health
Due Dates: June 17, 2025 | October 15, 2025 | February 13, 2026 | June 15, 2026 | October 15, 2026 | February 17, 2027 | June 15, 2027 | October 15, 2027
Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years. NIH intends to commit $27M in FY 2026 across this and companion NOFOs.
Summary: Supports confirmatory efficacy clinical trials of non-pharmacological and selected pharmacological interventions for mental disorders in adults and children, emphasizing experimental therapeutics and unmet therapeutic needs.
Key Information: Clinical trial required; strong preliminary evidence of target engagement and efficacy signal needed; limited to confirmatory efficacy stage (not initial development or effectiveness trials).
Description
This opportunity from the National Institute of Mental Health (NIMH) supports confirmatory efficacy clinical trials of non-pharmacological and, under certain conditions, pharmacological interventions for mental disorders in adults and children. The focus is on interventions that address unmet therapeutic needs and are consistent with the NIMH experimental therapeutics approach, which requires trials to test both clinical outcomes and mechanisms of action. The goal is to generate definitive evidence of efficacy and inform "go/no-go" decisions for further development, effectiveness testing, or dissemination.
Eligible interventions include behavioral, cognitive, interpersonal, and device-based (invasive or noninvasive) approaches, as well as certain pharmacological agents (primarily FDA-approved drugs being repurposed for new mental health indications). Trials must be sufficiently powered and designed to provide high scientific utility, regardless of outcome.
