Optimize and Predict Antidepressant Efficacy for Patient With Major Depressive Disorders Using Multi-omics Analysis and AI-predictive Tool
Trial ID: NCT06550037
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-08-07
Completion date: 2027-05-31
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
Conditions: Major Depressive Disorder
Locations: Università Degli Studi Di Siena
Countries: Italy
Enrollment: 350
Age range: 14 Years - 50 Years
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* Patients diagnosed with Major Depressive Disorder as certified by a SCID 5 (Structured Clinical Interview for DSM-5) for DSM-S for adults and K-SADS-PL-DSM 5 (Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime for DSM 5) for adolescents.
* Currently experiencing a major depressive episode with a HAM-D (Hamilton Depression) score of 18 or greater, or alternatively, a MADRS (Montgomery-Asberg Depression Rating Scale) score of 18 or greater.
* About to start a new antidepressant.
* Not concurrently starting a new psychotropic medication.
* Age 14-50 years.
* Able to use mobile devices (smart phone, tablet).
* Willingness to provide written informed consent to participate.

Exclusion Criteria:

* Intellectual disability.
* Neurological disease (multiple sclerosis, severe neurocognitive disorder, epilepsy).
* Current psychotic disorder or mood disorder with psychotic features.
* Primary diagnosis of alcohol or substance use disorder (DSM-5).
* Patients who started concomitant psychotropic medications less than one week ago.
* Active, ongoing inflammatory diseases (such as rheumatoid arthritis and rheumatic polymyalgia). or severe and unstable physical illness (such as recent myocardial infarction).
* A history of hepatitis B or C, human immunodeficiency virus, or evidence of active tuberculosis infection or any active systemic infection within 2 weeks prior to the start of the study.
* Use of antibiotics or other medications that may have affected the composition of the microbiota during the 30 days prior to baseline.
* Pregnancy and lactation.

Outcomes:
Identify neuroinflammatory indices; Microbiome analysis; Metabolomic analysis; Analysis of lipoprotein profile; Identify immune-profile linked and epigenomic signatures; AI-powered diagnostics predictive tool (companion diagnostic-like); Mood assessment through brain biomarker; Patient engagement digital tool; Discovery of a new set of biomarkers; Investigation of the gut-brain-axis and of the biomarkers of interest in the context of mental diseases starting with MDD