ProNET: Psychosis-Risk Outcomes Network

Site-PI Mittal at Northwestern University will participate as site #13 in the conduct of the ProNET: Psychosis-Risk Outcomes Network research project submitted in response to the National Institute of Mental Health Request for Applications RFA-MH-20-340: Clinical High Risk for Psychosis Research Network (U01 Clinical Trial Not Allowed). We will recruit 40 CHR subjects (10 in the 01 year, 20 in the 02 year, and 10 in the 03 year) and follow them with comprehensive outcome measures with eight visits over two years, including at screening and baseline and 1, 2, 3, 6, 12, 18, and 24 months. We will also obtain multimodal biomarker assessments (3T MRI, ERP, fluid sampling, natural language sampling) at baseline and passive and ecological momentary assessment throughout the project. Twenty comparison subjects (5 in the 01 year, 10 in the 02 year, and 5 in the 03 year) will also be assessed with clinical and biomarker measures at baseline. The site PI Mittal and Co-I Shankman will have share responsibility for the design, conduct, and reporting of the research with the applicant organization (Yale University) and will be responsible for programmatic decision making in the collection of data. Investigators from Northwestern will be coauthors on publications arising from the project. Mittal and Shankman understand that its performance will be evaluated in relation to the objectives of the project as determined by Yale University and the RFA-MH-20-340-required Data Processing Analysis and Coordinating Center, Steering Committee, and External Working Group. Mittal and Shankman will adhere to all applicable federal requirements in the event of an award.