Attention Deficit Hyperactivity DisorderPhase 4MIMOSANCT04272021
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2018to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
- drug naive
Who cannot join
- presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
- and previous treatment with psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Eugenio Medea
Bosisio Parini
Maria Nobile, MD, PhD, +39031877813, maria.nobile@lanostrafamiglia.it
About this study
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
standard therapy for ADHD
| Study group | Role | What they receive |
|---|---|---|
| ADHD sample | Experimental | Children with a diagnosis of ADHD Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD rating scale
Clinical improvement measured with ADHD rating scale, percentage.
Measured: 2-3 months
Secondary outcomes (1)
CGI-S
Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start13 Apr 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272021
- Sponsor's protocol ID
- 504
- Acronym
- MIMOSA
- Status last verified
- Aug 2022
- First submitted
- 13 Feb 2020
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
- ClinicalTrials.gov ID
- NCT04272021
- Acronym / sponsor ID
- MIMOSA / 504
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD sample | Experimental | Drug: MethylphenidateChildren with a diagnosis of ADHD |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
- drug naive
Key exclusion criteria (2 listed)
- presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
- and previous treatment with psychoactive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidatestandard therapy for ADHD | Drug | ADHD sample |
Primary outcome
ADHD rating scale
Time frame: 2-3 months
Clinical improvement measured with ADHD rating scale, percentage.
1 secondary outcome
CGI-S
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Nobile, MD, PhD (+39 031877813, maria.nobile@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD rating scale (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.