Attention Deficit Hyperactivity DisorderNCT00143767
Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The primary purpose of this study is to investigate brain whether ADHD represents a disruption or a delay of brain development. Children and adolescents both with and without ADHD are asked to participate in several MRI sessions, two years apart. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to not given
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 6 - 18 years at initial MRI
- DSM-IV (APA, 1994) diagnosis of ADHD, according to DISC interview
- Scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form(TRF)
- No DSM-IV (APA, 1994) diagnosis, according to DISC interview
- No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
Who cannot join
- IQ < 70
- Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
- Presence of metal objects in or around the body (pacemaker, dental braces)
- History of or present neurological disorder
- For individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Dept. of Child and Adolescent Psychiatry, UMC Utrecht
Utrecht
Janna van Belle, M.Sc., +31 30 250 3275, J.vanBelle@umcutrecht.nl
Janna van Belle, M.Sc.
About this study
The primary purpose of this study is to investigate brain whether ADHD represents a disruption or a delay of brain development. Children and adolescents both with and without ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to chart brain development over time, both in typical development and ADHD, and therefore to address whether ADHD represents a disruption or a delay of typical brain development.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric disorder of childhood, occurring in 3 to 5% of all school-age children. This disorder is associated with greater risks for low academic achievement, school dropouts, poor family and peer relations, aggression, substance abuse, driving accidents and chronic problems in adult adaptation. As such, it has an enormous impact on the utilization of medical and health care services, and the direct and indirect costs of this disorder are high. However, in a large number of children symptoms dissipate as they grow up and they go on to function normally and lead typical lives. This has lead to speculation that ADHD may not so much represent a disruption, as a delay of brain development. This aim of this study is to address this issue.
There is a growing body of research supporting the existence of deficits in brain anatomy associated with ADHD, with evidence of reductions in overall brain size, cortical gray matter and subcortical structures. However, reported effect sizes are small and results not always consistent. Anatomical MRI studies may be easily confounded, as brain development is complex and associated with both progressive and regressive changes in brain anatomy. In this study, we propose to combine longitudinal data from a large cohort of children and adolescents with state-of-the-art imaging methods (including diffusion tensor imaging and voxelbased morphometry) to investigate brain development in ADHD. This will allow us to address the question whether ADHD represents a disruption or a delay of brain development.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startAug 2005
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 UMC UtrechtThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Sarah Durston, Ph.D., Principal investigator, Rudolf Magnus Institute of Neuroscience, University Medical Center UtrechtHerman van Engeland, M.D. Ph.D., Study chair, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143767
- Sponsor's protocol ID
- METC 05/036
- Status last verified
- Mar 2007
- First submitted
- 31 Aug 2005
- Last updated
- 20 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00143767
- Acronym / sponsor ID
- METC 05/036
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Aug 2005
- First posted
- 2 Sep 2005 (estimated)
- 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.
The primary purpose of this study is to investigate brain whether ADHD represents a disruption or a delay of brain development. Children and adolescents both with and without ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to chart brain development over time, both in typical development and ADHD, and therefore to address whether ADHD represents a disruption or a delay of typical brain development.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric disorder of childhood, occurring in 3 to 5% of all school-age children. This disorder is associated with greater risks for low academic achievement, school dropouts, poor family and peer relations, aggression, substance abuse, driving accidents and chronic problems in adult adaptation. As such, it has an enormous impact on the utilization of medical and health care services, and the direct and indirect costs of this disorder are high. However, in a large number of children symptoms dissipate as they grow up and they go on to function normally and lead typical lives. This has lead to speculation that ADHD may not so much represent a disruption, as a delay of brain development. This aim of this study is to address this issue.
There is a growing body of research supporting the existence of deficits in brain anatomy associated with ADHD, with evidence of reductions in overall brain size, cortical gray matter and subcortical structures. However, reported effect sizes are small and results not always consistent. Anatomical MRI studies may be easily confounded, as brain development is complex and associated with both progressive and regressive changes in brain anatomy. In this study, we propose to combine longitudinal data from a large cohort of children and adolescents with state-of-the-art imaging methods (including diffusion tensor imaging and voxelbased morphometry) to investigate brain development in ADHD. This will allow us to address the question whether ADHD represents a disruption or a delay of brain development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 6 - 18 years at initial MRI
- DSM-IV (APA, 1994) diagnosis of ADHD, according to DISC interview
- Scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form(TRF)
- No DSM-IV (APA, 1994) diagnosis, according to DISC interview
- No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
Key exclusion criteria (5 listed)
- IQ < 70
- Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
- Presence of metal objects in or around the body (pacemaker, dental braces)
- History of or present neurological disorder
- For individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
- Lab homepage with info for subjects (in Dutch)Link provided by the sponsor.
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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.
Sarah Durston, Ph.D. principal investigator
Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
Herman van Engeland, M.D. Ph.D. study chair
Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by UMC Utrecht at 1 site in Netherlands.
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 5 inclusion and 5 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 20 Mar 2007. 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 Netherlands. 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.
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 Sarah Durston, Ph.D. (+31 30 250 8161, S.Durston@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Mar 2007.