National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders funding opportunity, managed by the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH), aims to accelerate the development and early clinical evaluation of innovative drugs and devices for mental disorders. The grant supports multidisciplinary teams to discover and validate novel pharmacologic or neuromodulatory therapies and to conduct preclinical and early-stage human studies. The program promotes collaborations between academia, industry, and other partners to translate research discoveries into practical interventions for mental health conditions. The funding opportunity supports projects that develop pharmacologic and neuromodulatory tools, validate candidate therapies, and conduct early human studies. Research may involve large biologic molecules, gene-based and cell therapies, microbiome treatments, and neurostimulation devices. Key goals include target validation, proof-of-concept testing, safety and tolerability assessments, and tool development such as PET or SPECT imaging agents. Applications may include mechanistic studies in humans, integration of AI and machine learning in drug discovery, or development of novel biomarkers and neurophysiological measures. Eligible applicants include higher education institutions, nonprofit and for-profit organizations, local, state, and federal governments, and certain tribal and housing authorities. Applications must follow NIH submission guidelines and utilize systems like ASSIST, Grants.gov, or institutional S2S platforms. Registration in SAM, eRA Commons, and Grants.gov is required. Investigators must follow detailed application instructions including milestone plans, data management and sharing plans, and human subject protection protocols if applicable. Application deadlines occur multiple times annually with the earliest due date on February 25, 2025, followed by regular quarterly cycles through October 25, 2027. A letter of intent is encouraged 30 days before each due date. The earliest application submission date is January 25, 2025. Awards are anticipated based on merit review cycles, and start dates may range from December 2025 to July 2028 depending on the application round. The program does not require cost-sharing and allows for new, renewal, and resubmission applications. Funding is provided through a cooperative agreement (U01) with substantial NIH involvement. Application budgets are not capped but must be justified based on project needs, with project periods limited to five years. The number of awards depends on available NIH appropriations and the number of meritorious proposals. Applicants may submit multiple distinct proposals. Key review criteria include significance, innovation, feasibility, investigator qualifications, and alignment with NIMH priorities. For additional information, applicants may contact the scientific lead, Dr. Yael Mandelblat-Cerf at yael.mandelblat-cerf@nih.gov, or reach out to Nicholas Gaiano for peer review questions at nick.gaiano@nih.gov. For grants management concerns, contact Heather Weiss at weissh@mail.nih.gov. All program details, application procedures, and requirements are outlined in PAR-25-352.