Status:
RECRUITING
Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and AI-predictive Tool
Lead Sponsor:
Alessio Fasano
Collaborating Sponsors:
University of Siena
Fundació Eurecat
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
14-50 years
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, ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06550037
Start Date
August 7 2023
End Date
May 31 2027
Last Update
November 17 2025
Active Locations (1)
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1
Università Degli Studi Di Siena
Siena, Italy, 53100