Early Stage Testing of Pharmacologic or Device-based Interventions for Mental Disorders

DUE: February 15, 2024

NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this FOA encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this FOA is intended to support early stage testing of pharmacologic or 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 dose-dependent neurophysiological/clinical/behavioral effect.