Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
Grant supports clinical trials testing non-pharmacological interventions for mental disorders in adults and children to address unmet therapeutic needs.
Funder: National Institutes of Health
Due Dates: February 17, 2027 (Applications) | June 15, 2027 (Applications) | October 15, 2027 (Applications; final deadline)
Funding Amounts: No application budget cap; project periods up to 5 years; no cost sharing required
Summary: Supports fully powered confirmatory efficacy trials of interventions for mental disorders in adults and children using an experimental therapeutics approach.
Key Information: Prior evidence of target engagement, initial target validation, and a preliminary efficacy signal are required.
Description
The National Institute of Mental Health (NIMH) supports confirmatory efficacy clinical trials through this NIH R01 opportunity, PAR-25-179. The program focuses on non-pharmacological therapeutic and preventive interventions addressing unmet needs in mental disorders in adults and children. Approaches include behavioral, cognitive, interpersonal, technology-assisted, and invasive or noninvasive device-based interventions, alone or in combination. Selected pharmacological interventions may also qualify.
Trials must use an experimental therapeutics approach, measuring the intervention’s hypothesized mechanism of action and testing whether changes in that mechanism relate to clinical or functional improvement. Both positive and negative findings should inform decisions about further development, effectiveness testing, or dissemination. Interventions must already have a compelling scientific rationale and preliminary evidence supporting confirmatory testing, rather than requiring initial development or optimization.
