Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children

Phase 4UnknownNCT04272021

IRCCS Eugenio Medea20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

ADHD rating scale

Clinical improvement measured with ADHD rating scale, percentage.

Time frame: 2-3 months

Secondary Outcomes

CGI-S

Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )