Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)

This grant, called Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression, has a primary goal of supporting the creation of accurate biomarkers and tools. These tools will assist in predicting an individual's response to different treatments for depression.

The grant is broken into two phases. The first phase will span up to two years and involves initial studies to validate the technology used for these tools. This will involve retrospective secondary analyses of data from completed clinical trials and quick, small-scale pilot studies. The aim here is to ensure that there is sufficient evidence to show that the technology has potential clinical usefulness. Various criteria like futility analyses, receiver operating characteristic (ROC) curves, and the measure of effect size will be evaluated to decide if the studies should continue or stop.

In the second phase, slated to last up to five years, the innovators will move on to the practical testing of the efficacy of the biomarker or tool. They will design and conduct large-scale clinical trials that would stratify participants based on the biomarker or tool. The objective here is to surpass the effectiveness of the conventional clinician/patient treatment assignment which will act as the control group for comparison. The test group will be those who use the newly developed tool to inform treatment selection in depression. Both Clinical Trials and Non-Clinical trials are acceptable for this grant. The types of phased Funding Opportunity Announcements (FOA) acceptable for this project include either R33/R61 or UG3/UH3.