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

This grant supports cooperative-agreement early-stage clinical trials of novel investigational drugs or neuromodulatory devices for psychiatric disorders, including first-in-human and Phase II studies that assess target engagement, safety, tolerability and functional effects. It funds milestone-driven trials in pediatric and adult populations to generate data that de-risk novel mechanisms and attract further development funding.