Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
National Institutes of Health (NIH)
Total funding amount is unspecified.
NIH intends to commit a total of $27 million for FY 2026.
To support confirmatory efficacy testing of therapeutic and preventive interventions for mental disorders.
Focus on addressing unmet therapeutic needs and providing significant clinical benefits.
Adults and children with mental disorders.
Researchers and institutions involved in mental health interventions.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local governments, and federal agencies.
Specific qualifications include having the skills, knowledge, and resources necessary to carry out the proposed research.
Non-domestic (non-U.S.) entities are eligible to apply.
Foreign components of U.S. organizations are allowed.
Focus on confirmatory efficacy trials of non-pharmacological and pharmacological interventions.
Interventions must be based on compelling scientific rationale and previous demonstration of efficacy.
Application budgets are not limited but must reflect the actual needs of the proposed project.
Application deadlines include various dates, with the latest being October 15, 2027.
All applications are due by 5:00 PM local time of the applicant organization.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Applications will be evaluated for scientific and technical merit through the NIH peer review system.
Applications will undergo a selection process based on scientific merit and relevance to program priorities.
Overall impact score reflecting the likelihood for the project to exert a sustained influence on the research field.
Applications must propose clinical trials and adhere to the experimental therapeutics approach.
Applications that do not meet the specified criteria for confirmatory efficacy testing will not be reviewed.
Encouragement to leverage existing resources and infrastructure for efficient collaborations.
Strong emphasis on scientific rigor and feasibility in proposed interventions.
Demonstrating a compelling scientific rationale and preliminary efficacy signal.
Submitting applications that do not comply with the application instructions.
Engage with NIH staff early to discuss potential clinical practice impacts.
Focus on addressing specific functional domains or symptoms of mental disorders.