NCT04272021

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

5.6 years

First QC Date

February 13, 2020

Last Update Submit

August 4, 2022

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • ADHD rating scale

    Clinical improvement measured with ADHD rating scale, percentage.

    2-3 months

Secondary Outcomes (1)

  • CGI-S

    2-3 months

Other Outcomes (1)

  • Change in functional neuroimaging

    2-3 months

Study Arms (1)

ADHD sample

EXPERIMENTAL

Children with a diagnosis of ADHD

Drug: Methylphenidate

Interventions

MethylphenidateDRUG

standard therapy for ADHD

ADHD sample

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
  • drug naive

You may not qualify if:

  • presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
  • and previous treatment with psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, Italy

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Maria Nobile, MD, PhD

CONTACT

+39 031877813maria.nobile@lanostrafamiglia.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

April 13, 2018

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

IT(1)