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

ID: PAR-25-179 • Type: Posted

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.
Background
The National Institute of Mental Health (NIMH) is part of the Department of Health and Human Services and is dedicated to transforming the understanding and treatment of mental illnesses through basic and clinical research.

The goal of this grant opportunity is to support confirmatory efficacy testing of both non-pharmacological and selected pharmacological interventions for mental disorders in adults and children, focusing on addressing unmet therapeutic needs through an experimental therapeutics approach.

Grant Details
This funding opportunity supports confirmatory efficacy trials designed to provide high scientific utility information that can guide further development, effectiveness testing, or dissemination of interventions.

Trials must be designed based on a compelling scientific rationale, previous demonstration of engagement with the hypothesized mechanism of action, and preliminary efficacy signals. Interventions may include behavioral, cognitive, interpersonal, device-based approaches (both invasive and non-invasive), or combinations thereof.

Pharmacological interventions primarily focus on FDA-approved drugs that are off-patent or undergoing development for new indications. The trials should measure the hypothesized mechanism of action and its relationship with clinical outcomes. Applications must demonstrate that the intervention has already shown preliminary evidence of target engagement and efficacy.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled, private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state/county governments, tribal governments, federal agencies, independent school districts, public housing authorities, faith-based organizations, regional organizations, and foreign entities. NIMH encourages applications from underrepresented groups.

Period of Performance
The maximum project period is 5 years; however, shorter durations are encouraged. The application process includes specific due dates for submission starting from January 14, 2025.

Grant Value
NIMH intends to commit a total of $27 million for FY 2026 to fund this NOFO along with its companion NOFOs. Application budgets are not limited but should reflect the actual needs of the proposed project.

Overview

Category of Funding
Health
Funding Instruments
Grant
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 11/26/24 the National Institutes of Health posted grant opportunity PAR-25-179 for Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). The grant will be issued under grant program 93.242 Mental Health Research Grants.

Timing

Posted Date
Nov. 26, 2024, 12:00 a.m. EST
Closing Date
Oct. 15, 2027, 12:00 a.m. EDT Due in 1046 Days
Last Updated
Nov. 27, 2024, 9:45 a.m. EST
Version
1
Archive Date
Nov. 20, 2027

Eligibility

Eligible Applicants
Public housing authorities/Indian housing authorities
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
City or township governments
Independent school districts
For profit organizations other than small businesses
County governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Info
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.

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-179.html

Documents

Posted documents for PAR-25-179

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