Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and AI-predictive Tool
NCT Number: NCT06550037
Acronym: OPADE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Major Depressive Disorder
Sponsor: Alessio Fasano
Collaborators: University of Siena|Fundació Eurecat|Perseus Biomics|ARTIFICIAL INTELLIGENCE EXPERT SRL|Mama Health Technologies GmbH|Protobios OU|Cephalgo|Biokeralty Research Institute|Sanitas University|Accare|Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta|Istanbul Medipol University Hospital|CEINGE|Fondazione di ricerca biomedica EBRIS
Sex: ALL
Age: CHILD, ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-07
Completion Date: 2027-05-31
Locations: Università Degli Studi Di Siena, Siena, 53100, Italy

Summary:
OPADE is a non-profit, observational, multicenter, open-label study aimed at defining personalized treatment for Major Depressive Disorder (MDD). In particular, we will combine genetics, epigenetics, microbiome, immune response data together with anamnesis, questionnaires, electroencephalography (EEG) collected from subjects suffering MDD. Eventually, an Artificial Intelligence (AI)/Machine Learning (ML) predictive tool will be created to guide clinicians in improving MDD treatment and patient's stratification.

Primary Outcome Measures: Identify neuroinflammatory indices, Several inflammatory markers such as G-CSF, GM-CSF, IFN-γ IL-10, IL-12p40, IL-15, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8/CXCL8, MCP-1/CCL2, TNF-α, TNFβ will be analysed., 2 years|Microbiome analysis, Identification of bacterial and fungal components., 2 years|Metabolomic analysis, The metabolomic analysis will involve three different groups of metabolites: 1) Intermediate of tryptophan metabolism (tryptophan, serotonin, 5-HIAA, quinurenin, quinurenic acid and other hormones and derivatives involved in the pathway) and others related to purines (paraxanthin/xanthin ratio); 2) L-acylcarnitines (including short chain, medium long-lasting acylcarnitine), with particular emphasis on laurylcarnitine and acetylcarnitine; 3) Phenolic (and related), such as phenolic acid, mandelic acid or methoxy-hydroxyphenyl glycol., 2 years|Analysis of lipoprotein profile, Different forms of lipoproteins will be evaluated: Apolipoproteins A1 and A2, HDL-apolipoproteins A1 and A2,free cholesterol HDL3, HDL3-apolipoprotein A1, HDL2-apolipoprotein A2, apolipoprotein A2, IDL, HDL-apolipoprotein A2, VLDL and its subtypes, VLDL2-triglycerides, VLDL3-triglyceridestriglycerides, VLDL2- cholesterol, VLDL3 cholesterol, VLDL4 cholesterol free of VLDL4, phospholipids VLDL2, Phospholipids VLDL3, Cholesterol LDL5, Cholesterol free LDL5, Phospholipids LDL5, LDL5-apolipoprotein B, HDL3 cholesterol, HDL4 cholesterol HDL4, HDL3 cholesterol free, free cholesterol HDL4, HDL3-phospholipids, HDL4-phospholipids, HDL3-apolipoprotein A1, HDL4-apolipoprotein A1, HDL3-apolipoprotein A2 and HDL4-apolipoprotein A2., 2 years|Identify immune-profile linked and epigenomic signatures, Methylome analysis on genomic DNA will be performed., 2 years|AI-powered diagnostics predictive tool, Deploy an AI-powered predictive tool (companion diagnostic-like) in clinical practice for the prescription of anti-depressants. OPADE AI-powered predictive tool will be a class C medical device under the In vitro diagnostic classification., 2 years|Mood assessment through brain biomarker, Validate a patient tracking tool for mood assessment using brain biomarker., 2 years|Patient engagement digital tool, Validate a patient engagement digital tool that can be deployed in any patient community to enhance clinical study outcomes., 2 years|Discovery of a new set of biomarkers, Propose new set of biomarkers that can guide the development of new antidepressants, 2 years|Investigation of the gut-brain-axis and of the biomarkers of interest in the context of mental diseases starting with MDD, Identify indices in MDD to improve diagnostic accuracy for primary prevention and patients' stratification., 2 years