OpportunityTitle: Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)
AdditionalInformationOnEligibility: 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.
Description: The goal of this phased FOA (either R33/R61 or UG3/UH3) is to accelerate the development of sensitive biomarkers/tools to predict individual treatment-response between two or more existing treatments for depression. In phase 1 (up to 2 years) preliminary studies (e.g., retrospective secondary analyses of data from completed clinical trials and/or in nimble, fast-fail pilot studies) will de-risk the test technology demonstrating that there is enough signal for clinical utility (futility analyses, ROC curves, and/or effect size will be evaluated as go/no-go criteria). Phase 2 (up to 5 years) innovators will prospectively test the efficacy of the biomarker/tool in large-scale biomarker/tool-stratified clinical trials with the goal of beating standard-of-care decision-making (i.e., clinician/patient treatment assignment will be the CTRL group vs the test).
GrantorContactEmailDescription: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
GrantorContactText: NIH Grants Information &lt;br/&gt;grantsinfo@nih.gov