First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

The National Institutes of Health (NIH) is seeking cooperative agreement applications to support early stage clinical trials of novel investigational drugs or neuromodulatory device-based interventions for psychiatric disorders. The purpose of this Notice of Funding Opportunity (NOFO) is to encourage the development of new treatments for psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations, including first in human (FIH) and Phase II studies of novel agents, as well as early feasibility studies (EFS) of novel devices. Key aspects of this opportunity include: • The development of novel mechanism of action investigational drugs or novel neuromodulatory devices for the treatment of psychiatric disorders. • The evaluation of target engagement, safety, tolerability, and efficacy of these interventions. • The formation of collaborative partnerships between biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development. • The goal of facilitating rapid collection of data to "de-risk" novel mechanism of action investigational drugs and devices, and to attract private or other public funding for further clinical development.