ADHDNCT05229627
Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD
An observational study of ADHD, run by Peking University Sixth Hospital.
Trial summary
Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- MPH and ATX
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 31 Dec 2023
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: the ADHD group would be recruited by the clinic for child psychiatry in Peking University sixth hospital; while the healthy control would be recruited in community setting
Who may be able to join
- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16
Who cannot join
- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) < 80
About this study
Official title: Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine
Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Methylphenidate(MPH) and Atomoxetine(ATX) are most frequently used for treating ADHD in many countries but the individual treatment response varies. Some patients present good response to either MPH or ATX with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. The underlying mechanism for the heterogenous responsiveness remains unknown. Thus we proposed to use multimodule magnetic resonance imaging(MRI) technology to explore the neural mechanisms of remission in children with ADHD treated with MPH or ATX.
Read the detailed description
the main aim of the current study is to explore the mechanism of remission in children with ADHD treated by MPH or ATX. Baseline information including demographic information, clinical features including ADHD symptoms, cognitive assessments such as executive function, MRI scans including resting state functional MRI, structural MRI, and DTI would be acquired in each participant. after 8-12 weeks of treating with MPH or ATX, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by MPH or ATX
- Conditions
- ADHD
- Being tested
- MPH, ATX
- Keywords
- multimodule MRI, remission, MPH, ATX, ADHD
- 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.
MPHDrug
Also called Concerta
the drug would be prescribed to patients without any contraindication
ATXDrug
Also called Strattera
the drug would be prescribed to patients without any contraindication
| Study group | Role | What they receive |
|---|---|---|
| healthy control | healthy controls, screened by K-SADS-PL | |
| MPH induced Remission | patients show remission after 8-12 weeks of treatment with MPH Receives: Drug: MPH | |
| non responder to MPH | patients don't show remission after 8-12 weeks of treatment with MPH Receives: Drug: MPH | |
| ATX induced remission | patients show remission after 8-12 weeks of treatment with ATX Receives: Drug: ATX | |
| non responder to ATX | patients don't show remission after 8-12 weeks of treatment with ATX Receives: Drug: ATX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)
to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up
Measured: 8 to 12 weeks
Clinical Global Impressions-Improvement scale (CGI-I)
to define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.
Measured: 8 to 12 weeks
resting state functional magnetic resonance imaging (rs-fMRI)
participants undergo resting state functional MRI (rs-fMRI) scan both in baseline and follow-up, and the duration for each rs-fMRI is 8 minutes.
Measured: 8 to 12 weeks
side effect assessment
with clinical global impression scale
Measured: 8 to 12 weeks
Secondary outcomes (5)
Structural magnetic resonance imaging (sMRI)
participants undergo structural magnetic resonance imaging (sMRI) scan both in baseline and follow-up, and the duration for each sMRI is 5 minutes.
Measured: 8 to 12 week
Diffusion Tensor Imaging (DTI)
participants undergo DTI scan both in baseline and follow-up, and the duration for each sMRI is 10 minutes.
Measured: 8 to 12 weeks
WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)
to assess the improvement of social function impairment in ADHD, participants will finish the WFIRS-P both in baseline and follow-up
Measured: 8 to 12 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
to assess the improvement of ecological executive function in ADHD, participants will finish the BRIEF both in baseline and follow-up
Measured: 8 to 12 weeks
The Cambridge Neuropsychological Tests Automated Battery（CANTAB）
to assess the improvement of neuropsychological executive function in ADHD, participants will finish the executive functional test measured by CANTAB both in baseline and follow-up
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study startJan 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Normal University
- Responsible party
- Principal investigator, Qingjiu Cao, Peking University Sixth Hospital
- Investigators
- Qingjiu Cao, PhD, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229627
- Sponsor's protocol ID
- NSFC81471382
- Status last verified
- Jan 2022
- First submitted
- 31 Dec 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: the data would be published first and not yet decided to share with other research groups
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine
- ClinicalTrials.gov ID
- NCT05229627
- Acronym / sponsor ID
- NSFC81471382
- Conditions
- ADHD
- Keywords
- multimodule MRI, remission, MPH, ATX, ADHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Normal University
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Feb 2022 (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.
Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Methylphenidate(MPH) and Atomoxetine(ATX) are most frequently used for treating ADHD in many countries but the individual treatment response varies. Some patients present good response to either MPH or ATX with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. The underlying mechanism for the heterogenous responsiveness remains unknown. Thus we proposed to use multimodule magnetic resonance imaging(MRI) technology to explore the neural mechanisms of remission in children with ADHD treated with MPH or ATX.
Detailed description
the main aim of the current study is to explore the mechanism of remission in children with ADHD treated by MPH or ATX. Baseline information including demographic information, clinical features including ADHD symptoms, cognitive assessments such as executive function, MRI scans including resting state functional MRI, structural MRI, and DTI would be acquired in each participant. after 8-12 weeks of treating with MPH or ATX, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by MPH or ATX
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | –healthy controls, screened by K-SADS-PL |
| MPH induced Remission | – | Drug: MPHpatients show remission after 8-12 weeks of treatment with MPH |
| non responder to MPH | – | Drug: MPHpatients don't show remission after 8-12 weeks of treatment with MPH |
| ATX induced remission | – | Drug: ATXpatients show remission after 8-12 weeks of treatment with ATX |
| non responder to ATX | – | Drug: ATXpatients don't show remission after 8-12 weeks of treatment with ATX |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- the ADHD group would be recruited by the clinic for child psychiatry in Peking University sixth hospital; while the healthy control would be recruited in community setting
Key inclusion criteria (1 listed)
- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16
Key exclusion criteria (1 listed)
- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) < 80
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 |
|---|---|---|
| MPHAlso: Concertathe drug would be prescribed to patients without any contraindication | Drug | MPH induced Remission, non responder to MPH |
| ATXAlso: Stratterathe drug would be prescribed to patients without any contraindication | Drug | ATX induced remission, non responder to ATX |
Primary outcome
Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)
Time frame: 8 to 12 weeks
to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up
Clinical Global Impressions-Improvement scale (CGI-I)
Time frame: 8 to 12 weeks
to define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.
resting state functional magnetic resonance imaging (rs-fMRI)
Time frame: 8 to 12 weeks
participants undergo resting state functional MRI (rs-fMRI) scan both in baseline and follow-up, and the duration for each rs-fMRI is 8 minutes.
side effect assessment
Time frame: 8 to 12 weeks
with clinical global impression scale
5 secondary outcomes
Structural magnetic resonance imaging (sMRI)
Time frame: 8 to 12 week
Diffusion Tensor Imaging (DTI)
Time frame: 8 to 12 weeks
WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)
Time frame: 8 to 12 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 8 to 12 weeks
The Cambridge Neuropsychological Tests Automated Battery（CANTAB）
Time frame: 8 to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: Undecided. the data would be published first and not yet decided to share with other research groups
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Qingjiu Cao, PhD principal investigator
Peking University Sixth Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Peking University Sixth Hospital.
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 1 inclusion and 1 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ) (time frame: 8 to 12 weeks). The study lists 4 primary outcomes in all. 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 8 Feb 2022.