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

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 Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Methylphenidate

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria Nobile, MD, PhD; Phone Number: +39 031877813; Email: maria.nobile@lanostrafamiglia.it

Study Locations

• Italy
  • Bosisio Parini, Italy
    • Recruiting
    • IRCCS Eugenio Medea
    • Contact: Maria Nobile, MD, PhD; Phone Number: +39031877813; Email: maria.nobile@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD sample; Children with a diagnosis of ADHD	Drug: Methylphenidate; standard therapy for ADHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD rating scale	Clinical improvement measured with ADHD rating scale, percentage.	2-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional neuroimaging	functional Near Infrared Spectroscopy	2-3 months

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: 504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No