Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and … (NCT06550037) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and AI-predictive Tool
Italy350 participantsStarted 2023-08-07
Plain-language 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.
Who can participate
Age range
14 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems focused on collecting biological samples and data — like gut microbiome, blood markers, and brain signals — rather than testing a new drug. Can you help me understand whether this study would change my actual treatment, or is it mainly contributing to future research?
2Since this trial is no longer enrolling new patients, does that mean my window to participate has passed, and if so, are there similar biomarker or AI-focused MDD studies I could still join?
3The study is measuring things like neuroinflammation and gut-brain-axis markers using what sounds like a lot of tests — blood work, microbiome samples, possibly brain imaging. What would the actual time commitment and number of procedures look like for someone in this trial?
4Given that this trial is trying to build an AI tool to predict which antidepressants work best, does my doctor think waiting for that kind of personalized prediction approach makes sense for my situation, or would starting a standard antidepressant treatment now be a better path?
5The study is collecting epigenomic and immune-profile data — does my doctor know whether any of those findings would be shared back with me, and could any of the results actually influence my personal care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify neuroinflammatory indices
Timeframe: 2 years
2
Microbiome analysis
Timeframe: 2 years
3
Metabolomic analysis
Timeframe: 2 years
4
Analysis of lipoprotein profile
Timeframe: 2 years
5
Identify immune-profile linked and epigenomic signatures