Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550037
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Optimize and Predict Antidepressant Efficacy for Patient With MDD Using Multi-omics Analysis and AI-predictive Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimize and Predict Antidepressant Efficacy for Patient With Major Depressive Disorders Using Multi-omics Analysis and AI-predictive Tool
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPADE
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 AIMachine Learning ML predictive tool will be created to guide clinicians in improving MDD treatment and patients stratification
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 31-39 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 patients conversations and monitoring herhis 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
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 patients conversations and monitoring herhis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None