Attention Deficit Hyperactivity Disorder Clinical Trial
— MIMOSAOfficial title:
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
NCT number | NCT04272021 |
Other study ID # | 504 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 13, 2018 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Eugenio Medea | Bosisio Parini |
Lead Sponsor | Collaborator |
---|---|
IRCCS Eugenio Medea |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in functional neuroimaging | functional Near Infrared Spectroscopy | 2-3 months | |
Primary | ADHD rating scale | Clinical improvement measured with ADHD rating scale, percentage. | 2-3 months | |
Secondary | CGI-S | Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" ) | 2-3 months |
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