NCT07570381Not yet recruiting
Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young Adults
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Exeter
- Diseases
- Autism
- NCT number
- NCT07570381
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Aug 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- OS1 Inclusion Criteria:
- Infants born very preterm (\<32 weeks) or extremely preterm (\<28 weeks); or
- Term-born infants with documented perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE); or
- Term-born infants with no risk factors (comparison group).
- Must be ≤12 months corrected age at enrolment.
- OS1 Exclusion Criteria:
- Syndromic, chromosomal, or known genetic conditions.
- Motor impairments that would prevent participation in psychometric or neurophysiology assessments.
- OS2 Inclusion Criteria:
- Individuals aged 5-25 years.
- Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD).
- Able to participate in scheduled assessments.
- OS2 Exclusion Criteria:
- Severe motor impairments that limit psychometric assessment.
- Diagnosis of schizophrenia, due to confounding neurocognitive effects.
Age in the registry: 6 months to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Exeter Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.