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NOT YET RECRUITING
NCT07570381

Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young Adults

Sponsor: University of Exeter

View on ClinicalTrials.gov

Summary

The PUREMIND OS1/OS2 study is a multinational, prospective, longitudinal observational study designed to identify early neurophysiological, biological, environmental, and psychosocial markers associated with neurodevelopmental and mental health conditions from infancy through young adulthood. Observational Study 1 (OS1) follows infants and toddlers at high risk for Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD) to discover biomarkers predictive of later clinical diagnosis, using EEG, fNIRS, psychometric assessments, and biological samples. Observational Study 2 (OS2) includes children, adolescents, and young adults with ASD, ADHD, or Developmental Coordination Disorder (DCD) to identify environmental and biological factors causally linked to anxiety and depression symptoms, and to support the development of personalised criteria for evidence-based interventions. Approximately 800 participants will be recruited across 10 international clinical sites. The study aims to generate multi-domain data to support predictive modelling and inform future personalised mental-health prevention strategies across childhood and young adulthood.

Official title: Biomarker Discovery for Predicting Autism Spectrum Disorder and Attention/Hyperactivity Disorders, and Identification of Environmental Factors Influencing Anxiety and Depression in Children, Adolescents, and Young Adults

Key Details

Gender

All

Age Range

6 Months - 25 Years

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2026-08-01

Completion Date

2028-12-31

Last Updated

2026-05-06

Healthy Volunteers

Yes

Locations (1)

University of Exeter

Exeter, United Kingdom