This grant is for conducting a Proof-of-Principle (PoP) clinical trial within the Clinical High Risk (CHR) for Psychosis network, utilizing a subset of drug development tools. The primary objective is to determine if selected compounds can produce a detectable biological and/or clinical signal in CHR individuals over a 12-16 week study period. The trial will rigorously assess the efficacy of various clinical outcome measures, including PSYCHS, alongside biological indicators. Compounds chosen for testing must specifically target a pathophysiologically relevant mechanism, ensuring their potential to yield observable signals on both biological and clinical measures within the defined study duration. This effort aims to accelerate the development of effective interventions for those at elevated risk of psychosis.
Opportunity ID: 349226
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-24-150 |
| Funding Opportunity Title: | Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical High Risk for Psychosis Clinical Trial Network (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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: | Jul 12, 2023 |
| Last Updated Date: | Jul 12, 2023 |
| Original Closing Date for Applications: | Oct 17, 2023 |
| Current Closing Date for Applications: | Oct 17, 2023 |
| Archive Date: | Nov 22, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments |
| 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | To use a subset of drug development tools, which are being assessed in the AMP SCZ observational study, in a PoP trial with CHR individuals to determine the ability to detect a biological and/or clinical signal with the compound or compounds selected to use within a 12-16 week study period. The PoP trial will assess the performance of the PSYCHS, other clinical outcome measures, and biological measures. The compound or compounds that are selected for testing in the CHR Clinical Trial Network will affect a pathophysiologically relevant mechanism and have the potential to produce a detectable signal on biological and clinical outcome measures within a 12-16 week period of study. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-24-150.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
There are no related documents on this grant.
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-H | Use for due dates on or after January 25, 2023 | PKG00282515 | Sep 17, 2023 | Oct 17, 2023 | View |
Package 1
Mandatory forms
349226 RR_SF424_5_0-5.0.pdf
349226 PHS398_CoverPageSupplement_5_0-5.0.pdf
349226 RR_OtherProjectInfo_1_4-1.4.pdf
349226 PerformanceSite_4_0-4.0.pdf
349226 RR_KeyPersonExpanded_4_0-4.0.pdf
349226 PHS398_ResearchPlan_5_0-5.0.pdf
349226 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
349226 RR_Budget_3_0-3.0.pdf
349226 RR_SubawardBudget30_3_0-3.0.pdf
349226 PHS398_ModularBudget_1_2-1.2.pdf
349226 PHS_AssignmentRequestForm_3_0-3.0.pdf
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