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

NCT07570381 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Autism Spectrum Disorder (ASD)
  • Developmental Coordination Disorder (DCD)

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • University of Dublin, Trinity College

    collaborator OTHER

  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER

  • Jimma University

    collaborator OTHER

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

    collaborator OTHER

  • The International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator UNKNOWN

  • University of Bari Aldo Moro

    collaborator OTHER

  • University of Exeter

    lead OTHER

Principal Investigators

  • Christopher Fox, MD · University of Exeter

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570381 on ClinicalTrials.gov