Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)
Funding for early-stage trials testing drugs or devices for mental disorder treatment, focusing on clinical effects and underlying mechanisms.
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; up to 5 years total (2 years R61, 3 years R33); $27M total program funding (FY26, across NOFOs)
Summary: Supports early-stage clinical trials of novel pharmacologic or neuromodulatory device-based interventions for mental disorders, requiring both clinical effect and mechanistic evaluation.
Key Information: R61/R33 biphasic structure; clinical trial required; both phases must be proposed; foreign and domestic applicants eligible.
Description
This opportunity from the National Institute of Mental Health (NIMH) supports early-stage clinical trials of pharmacologic interventions with novel mechanisms of action or neuromodulatory device-based interventions for the treatment of mental disorders. The program uses a biphasic R61/R33 mechanism, requiring applicants to propose both phases in a single application. Projects must use an experimental therapeutics approach, evaluating both the clinical effects of the intervention and the underlying mechanisms of action (e.g., target engagement, neurophysiological/behavioral effects).
The R61 phase focuses on milestone-driven, proof-of-mechanism studies (e.g., target engagement, dose-response), while the R33 phase supports further validation in a larger sample and assessment of the relationship between target engagement and clinical/functional outcomes. Both pediatric and adult/geriatric interventions are eligible. Studies must include objective measures of target engagement and be designed so that even negative results are informative.
