Personalized treatment for Major Depressive Disorder using multi-omics and AI

Optimize and Predict Antidepressant Efficacy for Patient With Major Depressive Disorders Using Multi-omics Analysis and AI-predictive Tool

This study is trying to find personalized treatment plans for people with Major Depressive Disorder by looking at their genetics and other biological factors to see if it can help them feel better.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 14 Years to 50 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Siena)
• Trial ID: NCT06550037 on ClinicalTrials.gov

What this trial studies

This observational study aims to define personalized treatment strategies for patients with Major Depressive Disorder (MDD) by integrating multi-omics data, including genetics, microbiome, and immune response. A total of 350 patients aged 14 to 50 will be enrolled and monitored over 24 months through six follow-up visits, during which psychometric assessments and biological samples will be collected. The study will utilize an AI predictive tool to analyze the data and improve treatment outcomes for MDD patients based on their individual profiles.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 to 50 who have been diagnosed with MDD and are about to start a new antidepressant.

Not a fit: Patients with intellectual disabilities, neurological diseases, or current psychotic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized antidepressant treatments for patients with MDD.

How similar studies have performed: While the integration of multi-omics and AI in treatment personalization is a novel approach, similar studies have shown promise in other areas of medicine.

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.

Where this trial is running

Siena

• Università Degli Studi Di Siena — Siena, Italy (RECRUITING)

Study contacts

• Study coordinator: Giulio Corrivetti, MD

Conditions: Major Depressive Disorder, Major Depressive Disorders, Microbiome, Metabolomic, Transcriptomics, Inflammation, Immune response profiling, Genetics