The Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required) funding opportunity, offered by the National Institute of Mental Health (NIMH), supports the early-stage testing of novel pharmacologic interventions or device-based therapies for mental disorders. This program emphasizes the experimental therapeutics approach, which seeks to understand both the clinical effects of interventions and the mechanisms underlying those effects.

This two-phased funding mechanism provides initial support through the R61 phase to evaluate target engagement and define parameters for further testing. Upon meeting defined milestones, projects may transition to the R33 phase, which supports continued testing to confirm mechanisms of action and assess dose-dependent effects on neurophysiological, clinical, or behavioral outcomes. This approach ensures that funded interventions are scientifically grounded and clinically meaningful.

Eligible applicants include a broad range of entities such as state and local governments, tribal governments and organizations, public and private higher education institutions, nonprofits, small businesses, and for-profit organizations. Minority-serving institutions, including Historically Black Colleges and Universities (HBCUs) and Hispanic-serving Institutions (HSIs), are encouraged to apply. International organizations are eligible under specific conditions.

Applications are accepted through October 15, 2027, with no specified funding ceiling or floor. Proposals must focus on testing novel mechanisms of action for pharmacologic or device-based interventions, with the goal of advancing the development pipeline for treatments addressing unmet needs in mental health care.

This opportunity supports innovative research that bridges basic science and clinical practice, fostering the development of cutting-edge treatments for psychiatric disorders. For detailed application requirements, refer to the full NOFO or contact NIH Grants Information at grantsinfo@nih.gov.