This funding opportunity supports cooperative agreements for first in human and Phase II clinical trials of novel investigational drugs and neuromodulatory devices targeting psychiatric disorders. It emphasizes milestone-driven studies assessing target engagement, pharmacological effects, safety, tolerability, and clinical efficacy in pediatric and adult populations. The goal is to de-risk novel treatments and foster collaborations between biomedical and industry researchers to advance FDA-approved therapies.
Eligible applicants include various government entities, higher education institutions, nonprofits, for-profit organizations excluding small businesses, tribal organizations, and other specified entities. Foreign organizations and foreign components of U.S. organizations are not eligible.
