Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01)

Submission Date: February 18, 2015

Award Ceiling: $1,000,000

The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support go/no-go decisions about further development or effectiveness testing of a targeted, scaled-up intervention. Intervention studies include, but are not limited to behavioral, cognitive, and interpersonal approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the interventions efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently- powered efficacy trial to determine the interventions potential for significant clinical benefit.

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