- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143767
Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder
Study Overview
Status
Conditions
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 Type
Enrollment
Contacts and Locations
Study Locations
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Utrecht, Netherlands
- Recruiting
- Dept. of Child and Adolescent Psychiatry, UMC Utrecht
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Contact:
- Janna van Belle, M.Sc.
- Phone Number: +31 30 250 3275
- Email: J.vanBelle@umcutrecht.nl
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Principal Investigator:
- Janna van Belle, M.Sc.
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Principal Investigator:
- Patrick de Zeeuw, M.Sc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 6 - 18 years at initial MRI
Inclusion Criteria for Subjects with ADHD:
- 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)
Inclusion Criteria for Controls:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Durston, Ph.D., Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
- Study Chair: Herman van Engeland, M.D. Ph.D., Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 05/036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
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University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
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Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCActive, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
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Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
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Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey