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

Open

National Institutes of Health

Deadline: Oct 15, 2027federal

Updated: Oct 30, 2025

Summary

The grant supports confirmatory efficacy clinical trials of non-pharmacological interventions for mental disorders in adults and children, aiming to address unmet therapeutic needs and enhance understanding of disease processes and intervention mechanisms. Eligible applicants include various nonprofit organizations, government entities, for-profit businesses, educational institutions, and other specified organizations such as Native American tribal governments and historically black colleges. Application details are not provided in the description; interested parties should refer to the full opportunity announcement for further instructions.

Full Description

Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.

Eligibility

Eligible applicants

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)
  • Other Native American tribal organizations

Government

  • County governments
  • Federally recognized Native American tribal governments
  • Special district governments
  • State governments
  • City or township governments
  • Public and Indian housing authorities

Business

  • For-profit organizations other than small businesses
  • Small businesses

Education

  • Private institutions of higher education
  • Independent school districts
  • Public and state institutions of higher education

Miscellaneous

  • Other

Additional information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Apply on official siteUpdated Oct 30, 2025

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