Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

Background
The National Institute of Mental Health (NIMH) is part of the Department of Health and Human Services and is dedicated to transforming the understanding and treatment of mental illnesses through basic and clinical research.

The goal of this grant opportunity is to support confirmatory efficacy testing of both non-pharmacological and selected pharmacological interventions for mental disorders in adults and children, focusing on addressing unmet therapeutic needs through an experimental therapeutics approach.

Grant Details
This funding opportunity supports confirmatory efficacy trials designed to provide high scientific utility information that can guide further development, effectiveness testing, or dissemination of interventions.

Trials must be designed based on a compelling scientific rationale, previous demonstration of engagement with the hypothesized mechanism of action, and preliminary efficacy signals. Interventions may include behavioral, cognitive, interpersonal, device-based approaches (both invasive and non-invasive), or combinations thereof.

Pharmacological interventions primarily focus on FDA-approved drugs that are off-patent or undergoing development for new indications. The trials should measure the hypothesized mechanism of action and its relationship with clinical outcomes. Applications must demonstrate that the intervention has already shown preliminary evidence of target engagement and efficacy.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled, private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state/county governments, tribal governments, federal agencies, independent school districts, public housing authorities, faith-based organizations, regional organizations, and foreign entities. NIMH encourages applications from underrepresented groups.

Period of Performance
The maximum project period is 5 years; however, shorter durations are encouraged. The application process includes specific due dates for submission starting from January 14, 2025.

Grant Value
NIMH intends to commit a total of $27 million for FY 2026 to fund this NOFO along with its companion NOFOs. Application budgets are not limited but should reflect the actual needs of the proposed project.