Funding Opportunities

NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. The purpose of this NOFO is to support the early-stage testing of pharmacologic interventions with novel mechanisms of action or neuromodulatory device-based interventions for the treatment of symptoms or domains of altered functions in individuals with mental illness. Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase), prior to full diagnostic criteria being met. Ultimately, this NOFO is intended to support early-stage testing of pharmacologic or neuromodulatory device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested to provide meaningful information where target modulation yields a well-controlled, dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult, and geriatric-focused interventions are appropriate for this NOFO. This R33 NOFO supports single-phased clinical trial awards.