Back to resultsMulti Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children (MIMOSA)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- IRCCS Eugenio MedeaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADHD sample
Arm Description
Children with a diagnosis of ADHD
Outcomes
Primary Outcome Measures
ADHD rating scale
Clinical improvement measured with ADHD rating scale, percentage.
Secondary Outcome Measures
CGI-S
Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04272021
Brief Title
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
Acronym
MIMOSA
Official Title
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADHD sample
Arm Type
Experimental
Arm Description
Children with a diagnosis of ADHD
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
standard therapy for ADHD
Primary Outcome Measure Information:
Title
ADHD rating scale
Description
Clinical improvement measured with ADHD rating scale, percentage.
Time Frame
2-3 months
Secondary Outcome Measure Information:
Title
CGI-S
Description
Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
Time Frame
2-3 months
Other Pre-specified Outcome Measures:
Title
Change in functional neuroimaging
Description
functional Near Infrared Spectroscopy
Time Frame
2-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Nobile, MD, PhD
Phone
+39 031877813
Email
maria.nobile@lanostrafamiglia.it
Facility Information:
Facility Name
IRCCS Eugenio Medea
City
Bosisio Parini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Nobile, MD, PhD
Phone
+39031877813
Email
maria.nobile@lanostrafamiglia.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
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