Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R33- Clinical Trial Required)
Funding for early testing of new drug or device treatments for mental disorders to understand mechanisms and assess clinical effects.
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; project period up to 3 years; total NIH/NIMH commitment for this and related NOFOs is $27M in FY 2026.
Summary: Supports early-stage clinical trials of novel pharmacologic or neuromodulatory device-based interventions for mental disorders, with a focus on understanding mechanisms and target engagement.
Key Information: Clinical trial required; strong preliminary data on target engagement is mandatory; limited submission—see eligibility.
Description
This opportunity, offered by the National Institute of Mental Health (NIMH) at NIH, funds early-stage clinical trials (R33 mechanism) to test novel pharmacologic or neuromodulatory device-based interventions for the treatment of mental disorders. The program emphasizes an experimental therapeutics approach: studies must both evaluate the clinical effects of the intervention and generate mechanistic information about the disorder or intervention response. The goal is to validate molecular or circuit-based targets and assess their association with neurophysiological, behavioral, or clinical outcomes.
Projects must demonstrate, through preliminary data, that the intervention can modulate the intended target in a dose-dependent manner in humans. Both pediatric and adult/geriatric studies are eligible. The program encourages applications for interventions not previously approved or marketed for psychiatric disorders, including repurposed drugs/devices and novel combinations (e.g., pharmacologic agent plus psychosocial intervention).
This R33 mechanism supports single-phase clinical trials and is not intended for first-in-human studies or for interventions already being tested in the same population/target elsewhere.
