Funding Opportunities

NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-inhuman, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. The purpose of this NOFO is to encourage pilot research developing and testing innovative psychosocial intervention approaches in which the target and/or intervention strategy is novel. Consistent with NIMH�s experimental therapeutics approach, this NOFO is intended to speed the translation of emergent research on mechanisms and processes underlying mental disorders into promising novel psychosocial preventative or therapeutic interventions. Targets may include, but are not limited to, potentially modifiable behavioral, cognitive, affective, and/or interpersonal factors or processes, neural circuits or neural activity subserving specific behaviors or cognitive processes, and/or other neurobiological mechanisms. Novel psychosocial interventions may be standalone interventions or novel augmentations to efficacious interventions for which there is an empirical rationale by which the augmentation (and corresponding target) is expected to substantially enhance outcomes. Support will be provided for up to two years (R61 phase) for preliminary milestone-driven testing of a novel intervention's impact on a target process or mechanism associated with mental disorder risk, causation, or maintenance (target engagement). Up to 3 years of additional support (R33 phase) will be provided for studies with findings that meet the "go/no-go" milestones embedded in the R61 phase. The R33 phase is intended to support the replication of target engagement and to test whether engaging the intervention target/mechanism mediates changes in clinical outcomes. Ultimately, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support "go/no-go" decisions about further development and/or testing of the intervention.