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 encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action investigational drugs or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials, including First-in-human (FIH), Phase Ib, Phase II/PoC and early feasibility studies (EFS), in pediatric and adult populations. These studies are designed to objectively and dose dependently assess target engagement in the central nervous system (CNS), along with safety and tolerability. Phase II/PoC studies additionally must evaluate the drug�s/device�s impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The overall objective of this NOFO is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding (when appropriate) for further clinical development as Food and Drug Administration (FDA)-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.