National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional) - PAR-25-352
Funder
National Institutes of Health
LOI Deadline
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LOI Required
Recommended, but not required
Application Deadline
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Maximum Project Duration
5 years
Research Focus Areas
New
Pharmacology
Pharmacotherapy
Mental Health Treatments/Interventions
Neurobiology/Neuroscience
Brain Stimulation Therapies/Neuromodulation (TMS, VNS, DBS, ECT)
Research Methods
Magnetic Resonance Imaging (MRI)/Other Imaging
Randomized Control Trials (RCT)
Description
The purpose of this notice of funding opportunity (NOFO) is 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. This NOFO encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged.