Attention Deficit Hyperactivity Disorder
Conditions
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.
Interventions
DRUGMethylphenidate
standard therapy for ADHD
Sponsors
IRCCS Eugenio Medea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD rating scale | 2-3 months | Clinical improvement measured with ADHD rating scale, percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-S | 2-3 months | Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = normal, not ill; maximun value: 7 = very severely ill ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in functional neuroimaging | 2-3 months | functional Near Infrared Spectroscopy |
Countries
Italy
Contacts
Primary ContactMaria Nobile, MD, PhD
Outcome results
None listed