The National Institute of Mental Health (NIMH) is offering this grant to support confirmatory efficacy clinical trials for both non-pharmacological and pharmacological interventions targeting mental disorders. This initiative is designed for treatments applicable to adults and children, aiming to address existing unmet therapeutic needs. This grant is for the purpose of advancing mental health science through an experimental therapeutics approach. It emphasizes the design of clinical trials to significantly enhance understanding of the relationship between underlying disease processes and the specific mechanisms through which interventions achieve therapeutic change. This aligns with NIMH’s ongoing commitment to fostering innovative and effective mental health treatments.
Opportunity ID: 357423
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-179 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 27, 2024 |
| Last Updated Date: | Nov 27, 2024 |
| Original Closing Date for Applications: | Oct 15, 2027 |
| Current Closing Date for Applications: | Oct 15, 2027 |
| Archive Date: | Nov 20, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Independent school districts Private institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-179.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357423 Full Announcement-PAR-25-179 -> PAR-25-179-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289144 | Jan 14, 2025 | Oct 15, 2027 | View |
Package 1
Mandatory forms
357423 RR_SF424_5_0-5.0.pdf
357423 PHS398_CoverPageSupplement_5_0-5.0.pdf
357423 RR_OtherProjectInfo_1_4-1.4.pdf
357423 PerformanceSite_4_0-4.0.pdf
357423 RR_KeyPersonExpanded_4_0-4.0.pdf
357423 PHS398_ResearchPlan_5_0-5.0.pdf
357423 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357423 RR_Budget_3_0-3.0.pdf
357423 RR_SubawardBudget30_3_0-3.0.pdf
357423 PHS398_ModularBudget_1_2-1.2.pdf
357423 PHS_AssignmentRequestForm_4_0-4.0.pdf
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