Viewing Study NCT06299618


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Ignite Modification Date: 2025-12-26 @ 3:50 AM
Study NCT ID: NCT06299618
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-08-14
First Post: 2023-06-23
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
Sponsor: University College Cork
Organization:

Study Overview

Official Title: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ENIGMA-I
Brief Summary: The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.
Detailed Description: The goal of this observational study is:

1. to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
2. to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: