Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33)
Funds a feasibility phase then a testing phase for a novel-mechanism drug or a device for mental disorders, with milestones between them.
The institute requires an experimental therapeutics approach for developing and testing treatments, and this notice is where that requirement bites hardest. Studies must both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying the disorder or the response to treatment.
Two kinds of intervention qualify: pharmacologic ones with a novel mechanism…
Early-stage testing of pharmacologic interventions with novel mechanisms of action and device-based interventions for mental disorders, using protocol designs that adequately test the presumed mechanism of action and show whether target modulation yields a dose-dependent neurophysiological, clinical or behavioural effect, under the institute's experimental therapeutics approach. A clinical trial is required. The mechanism is phased.
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