The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional) funding opportunity, issued by the National Institute of Mental Health (NIMH), seeks to support innovative research on novel pharmacologic and neuromodulatory tools for mental health treatment. This initiative aims to accelerate the discovery, preclinical development, and proof-of-concept testing of candidate drugs and devices for mental disorders, focusing on innovative interventions that target biological mechanisms and neural circuits associated with psychiatric conditions. Partnerships between academia and industry are strongly encouraged.

This program supports multidisciplinary teams conducting multi-project research to discover and validate therapeutic agents or devices addressing unmet needs in mental health. Areas of interest include novel pharmacological agents, neuromodulation devices, and tools to advance understanding of mental health conditions. Research may range from target identification and validation to early-stage human studies, including first-in-human clinical trials. The initiative also supports the development of biomarkers and imaging tools for evaluating therapeutic engagement and efficacy.

Eligible applicants include higher education institutions, nonprofit organizations, for-profit organizations, state and local governments, tribal entities, and faith-based or community organizations. Foreign organizations are not eligible to apply, though foreign components are allowed in applications. Partnerships between academic institutions and private-sector entities are encouraged to leverage combined expertise and resources. No cost-sharing is required, and organizations may submit multiple applications if they are scientifically distinct.

Applications must include multiple components, such as administrative cores, scientific cores, and research projects, with page limits specified for each component. Required elements include a milestone plan, clinical and data monitoring plans for clinical trials, and strategies for managing multi-component projects. A letter of intent, while not mandatory, is encouraged to aid in review planning and is due 30 days before the application deadline.

Application budgets are not capped but must align with project needs. The maximum project period is five years. Key deadlines include submission dates of February 25, June 25, and October 25 annually through October 25, 2027. Applications must be submitted through ASSIST or institutional systems and conform to NIH’s detailed application instructions. Proposals will be evaluated for scientific merit, innovation, feasibility, and alignment with NIMH priorities.

Awardees will be required to adhere to NIH policies for data sharing, safety monitoring, and ethical standards for human subjects research. Regular reporting will include milestones, financial updates, and progress on research objectives. The program offers a collaborative framework to accelerate mental health research and translate basic science discoveries into therapeutic applications for individuals with mental disorders. For additional details, applicants can contact NIMH program staff or access guidance provided in the funding announcement.