The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional) funding from the National Institute of Mental Health (NIMH) seeks to accelerate innovative drug and device therapies translation from discovery to early human studies. Studies appropriate for this NOFO will develop pharmacologic and neuromodulatory tools for basic and clinical research on mental health disorders; develop and validate tools (pharmacologic or neurostimulation) in support of experimental therapeutic studies of innovative candidates for mental disorders; and support early-stage human studies to rapidly assess the safety, tolerability, and pharmacodynamics of promising drug candidates/devices and new indications for novel Investigational New Drug (IND)-ready agents or Investigational Device Exemption (IDE)-ready devices for the treatment of mental disorders.Exemption (IDE)-ready devices for the treatment of mental disorders.
A U01 application can include no more than a single Research Project. Applications proposing two or more Research Projects along with Scientific and/or Administrative Core components should respond to the companion NOFO utilizing the U19 mechanism.
Applications are open to researchers in the USA. The award provides research funding for up to 5 years.
Opportunity number: PAR-25-352
Applications close:
- June 25, 2026
- October 25, 2026
- February 25, 2027
- June 25, 2027
- October 25, 2027