The Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R33 Clinical Trial Required) funding opportunity, issued by the National Institute of Mental Health (NIMH), supports clinical trials testing new pharmacologic or device-based interventions for mental disorders. This program emphasizes an experimental therapeutics approach, evaluating both clinical outcomes and the underlying mechanisms of action.

Eligible applicants include state and local governments, public and private institutions of higher education, nonprofits, for-profit organizations, small businesses, tribal governments, and community-based organizations. International organizations and Historically Black Colleges and Universities (HBCUs), as well as other minority-serving institutions, are also eligible to apply.

The program aims to advance interventions with novel mechanisms of action, requiring a trial design that tests whether the intervention modulates its intended target and produces measurable neurophysiological, clinical, or behavioral effects. Projects should focus on early-stage development, with the potential for future efficacy trials.

Applications are accepted on a rolling basis through October 15, 2027. While there is no specific funding ceiling or floor, projects must justify their budgets based on scope and objectives. Cost-sharing or matching funds are not required.

This opportunity is part of NIMH's Clinical Trial Pipeline, designed to enhance the development of innovative treatments for mental disorders. For additional details, applicants can access the full NOFO or contact NIH Grants Information at grantsinfo@nih.gov.