Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- ADHD rating scale
Study Overview
Brief Summary
MIMOSA study aims to characterize from behavioral, neurophysiological and neurocognitive perspectives children and adolescents with attention deficit hyperactivity disorder (ADHD), in order to identify a possible biomarker of response to medication treatments. To achieve this aim, in the study children with ADHD (drug naive) are recruited and undergo behavioral and clinical screenings, neurocognitive profile, and neurophysiological evaluation with functional near infrared spectroscopy (fNIRS). ADHD group is evaluated before the beginning of medications, at first dose of medication (only imaging evaluation fNIRS), and after a period of two/three months of continuous treatment with medication.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
- •drug naive
Exclusion Criteria
- •presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
- •and previous treatment with psychoactive drugs
Arms & Interventions
ADHD sample
Children with a diagnosis of ADHD
Intervention: Methylphenidate (Drug)
Outcomes
Primary Outcomes
ADHD rating scale
Time Frame: 2-3 months
Clinical improvement measured with ADHD rating scale, percentage.
Secondary Outcomes
- CGI-S(2-3 months)