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

The National Institutes of Health (NIH) is seeking applications for the early stage testing of pharmacologic or neuromodulatory device-based interventions for the treatment of mental disorders. This opportunity is part of the NIH's Clinical Trial Pipeline and aims to support the development and testing of therapeutic interventions. The studies should both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. Key aspects of this opportunity include: • The development and testing of pharmacologic interventions with novel mechanisms of action or device-based interventions. • The use of a protocol design where the presumed mechanism of action of the intervention is adequately tested. • The provision of meaningful information on target modulation and its effects on neurophysiological, clinical, or behavioral outcomes.