NCT06550037Active, not recruiting
Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and AI-predictive Tool
Optimize and Predict Antidepressant Efficacy for Patient With Major Depressive Disorders Using Multi-omics Analysis and AI-predictive Tool
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 7 Aug 2023
- Primary completion date
- Apr 2027
- Lead sponsor
- Alessio Fasano
- Diseases
- Depression
- NCT number
- NCT06550037
What you commit to
- Study type: Observational
- Planned participants: 350
- From 7 Aug 2023 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who started concomitant psychotropic medications less than one week ago.
- 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.
Other illness
- 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).
- Active, ongoing inflammatory diseases (such as rheumatoid arthritis and rheumatic polymyalgia). or severe and unstable physical illness (such as recent myocardial infarction).
Other
- Intellectual disability.
- Pregnancy and lactation.
Who the study is looking for
- 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.
Age in the registry: 14 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università Degli Studi Di Siena Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.