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

Last updated: August 9, 2024
Sponsor: Alessio Fasano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Mood Disorders

Depression (Adult And Geriatric)

Treatment

N/A

Clinical Study ID

NCT06550037
Pro23479
  • Ages 14-50
  • All Genders

Study 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

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 Lifetimefor 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 DepressionRating 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

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 rheumaticpolymyalgia). or severe and unstable physical illness (such as recent myocardialinfarction).

  • A history of hepatitis B or C, human immunodeficiency virus, or evidence of activetuberculosis infection or any active systemic infection within 2 weeks prior to thestart of the study.

  • Use of antibiotics or other medications that may have affected the composition ofthe microbiota during the 30 days prior to baseline.

  • Pregnancy and lactation.

Study Design

Total Participants: 350
Study Start date:
August 07, 2023
Estimated Completion Date:
May 31, 2027

Study Description

Three hundred and fifty patients diagnosed with MDD will be enrolled for 24 months and divided into 4 groups according to age: 14-17 years (70 pediatric patients), 18-30 years (100 adult patients), 31-39 years (90 adult patients), 40-50 years (90 adult patients).

The study protocol includes 6 follow-up visits: T0 (enrollment), T1, T2, T3, T4, and T5. At each medical visit, psychometric questionnaires will be administered to the patients and contextual biological samples including blood, stool and saliva will be collected. The study will use a multi-omics approach including: metagenomic sequencing to characterize the microbiome composition; metabolomics to detect circulating metabolites; transcriptomics to quantify microRNAs; epigenomics to assess methylation variability between and within groups and immune assays to analyze the antibody immune response and inflammatory profiles (cytokines, interleukins and growth factors). Cortisol and lipoproteins will also be quantified. In parallel, cognitive assessment and emotional status will be recorded remotely by each patient via chatbot and wearable EEG devices, respectively. Specifically, the chatbot will collect patient's conversations and monitoring her/his feelings; the chat conversation will be than transformed in a machine-readable data. The EEG device is a mobile app that will also allows to associate brainwaves with patients' feelings.

Connect with a study center

  • Università Degli Studi Di Siena

    Siena, 53100
    Italy

    Active - Recruiting

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