NCT06550037

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Aug 2023May 2027

Study Start

First participant enrolled

August 7, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

July 24, 2024

Last Update Submit

March 17, 2026

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisordersMicrobiomeMetabolomicTranscriptomicsInflammationImmune response profilingGeneticsArtificial intelligenceMachine learningElectroencephalographyChatbotBiomarkersPersonalized medicine

Outcome Measures

Primary Outcomes (10)

  • 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 (companion diagnostic-like)

    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

Study Arms (4)

Pediatric patients affected by MDD

14-17 years (70 pediatric patients)

Group 1 of adult patients affected by MDD

18-30 years (100 adult patients)

Group 2 of adult patients affected by MDD

31-39 years (90 adult patients)

Group 3 of adult patients affected by MDD

40-50 years (90 adult patients)

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Major Depressive Disorders

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Degli Studi Di Siena

Siena, 53100, Italy

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Periodic collection of blood, stool and saliva samples from enrolled patients.

MeSH Terms

Conditions

Depressive Disorder, MajorInflammation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 12, 2024

Study Start

August 7, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

IT(1)