Back to Funding Opportunities

Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required) - PAR-25-184

Funder
National Institutes of Health
LOI Deadline
LOI Required
Recommended, but not required
Application Deadline
Maximum Project Duration
5 years
Research Focus Areas
Mental Health Treatments/Interventions
Pharmacology
Pharmacotherapy
Neurobiology/Neuroscience
Brain Stimulation Therapies/Neuromodulation (TMS, VNS, DBS, ECT)
Bipolar Disorders
Anxiety Disorders
Schizophrenia and Psychosis/Psychotic Disorders
Research Methods
Randomized Control Trials (RCT)
Description
NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. The purpose of this NOFO is to support the early stage testing of pharmacologic interventions with novel mechanisms of action or neuromodulatory device-based interventions for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g., schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder). Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase) prior to full diagnostic criteria being met. Ultimately, this NOFO is intended to support evaluation of pharmacologic or neuromodulatory device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a well-controlled, dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult, and geriatric-focused interventions are appropriate for this NOFO.