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Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required) - PAR-25-179

Funder
National Institutes of Health
LOI Deadline
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LOI Required
Recommended, but not required
Application Deadline
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Maximum Project Duration
5 years
Research Focus Areas
Mental Health Treatments/Interventions
Pharmacology
Pharmacotherapy
Research Methods
Randomized Control Trials (RCT)
Description
NIMH solicits clinical trial applications through a series of notices 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 confirmatory efficacy testing of non-pharmacological preventive and therapeutic interventions, and under certain conditions, selected pharmacological interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this NOFO, 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, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to, behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) approaches, or a combination thereof. Pharmacological interventions to be studied under this grant mechanism are expected to primarily focus on drugs approved for marketing by the FDA (for any indication). These will include medications off-patent which are undergoing development for a new mental health indication.