Attention Deficit Hyperactivity DisorderNCT00161161
Genetic Liability in the Brain Morphology of Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with onset in childhood. Twin and adoption studies indicate that additive genetic factors explain up to 80% of the variance underlying susceptibility. Read more about this study
- Who is it for?
- Ages 7 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 1999to Dec 2002
- 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 7 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 7 - 18 years.
- DSM-IV (APA, 1994) diagnosis of ADHD (combined subtype), according to DISC interview
- scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
- one brother who meets the inclusion criteria for siblings
- no DSM-IV (APA,1994) diagnosis for ADHD or another disruptive disorder (ODD or CD), according to DISC interview
- no 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
- illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
- the presence of metal objects in or around the body (pacemaker, dental braces)
Trial locations and contacts
1 site in 1 country.
About this study
Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with onset in childhood. Twin and adoption studies indicate that additive genetic factors explain up to 80% of the variance underlying susceptibility. The siblings of children with ADHD have a three- to fivefold increased risk of having ADHD compared to the siblings of healthy control subjects, and the risk is even greater for monozygotic twins with 50-80% concordance compared with up to 33% in dizygotic twins). As full siblings share on average 50% of their genes, even the unaffected siblings of children with ADHD would be expected to share some of the genes involved in the disorder. The neuroanatomical substrate of ADHD is becoming increasingly better defined by a growing body of evidence from imaging studies. Evidence from neuroimaging studies suggests that this disorder is associated with reductions in brain volume up to 5% in these children. In this protocol we collected MRI-scans from boys with ADHD and their unaffected siblings, as well as control subjects. In addition, cheekswabs were later collected for DNA analysis.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD; MRI; genetics
- 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 posted12 Sep 2005 (estimated)
- Study startOct 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Brain Foundation
- Investigators
- Sarah Durston, Ph.D., Principal investigator, RMI of Neuroscience, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161161
- Sponsor's protocol ID
- WOM 99/076
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 30 Dec 2005
- Results posted
- No
Publications
Durston S, Hulshoff Pol HE, Schnack HG, Buitelaar JK, Steenhuis MP, Minderaa RB, Kahn RS, van Engeland H. Magnetic resonance imaging of boys with attention-deficit/hyperactivity disorder and their unaffected siblings. J Am Acad Child Adolesc Psychiatry. 2004 Mar;43(3):332-40. doi: 10.1097/00004583-200403000-00016.
PubMed 15076267Durston S, Fossella JA, Casey BJ, Hulshoff Pol HE, Galvan A, Schnack HG, Steenhuis MP, Minderaa RB, Buitelaar JK, Kahn RS, van Engeland H. Differential effects of DRD4 and DAT1 genotype on fronto-striatal gray matter volumes in a sample of subjects with attention deficit hyperactivity disorder, their unaffected siblings, and controls. Mol Psychiatry. 2005 Jul;10(7):678-85. doi: 10.1038/sj.mp.4001649.
PubMed 15724142
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Liability in the Brain Morphology of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00161161
- Acronym / sponsor ID
- WOM 99/076
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD; MRI; genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- The Dutch Brain Foundation
- Study start
- Oct 1999
- Study completion
- Dec 2002
- First posted
- 12 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.
Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with onset in childhood. Twin and adoption studies indicate that additive genetic factors explain up to 80% of the variance underlying susceptibility. The siblings of children with ADHD have a three- to fivefold increased risk of having ADHD compared to the siblings of healthy control subjects, and the risk is even greater for monozygotic twins with 50-80% concordance compared with up to 33% in dizygotic twins). As full siblings share on average 50% of their genes, even the unaffected siblings of children with ADHD would be expected to share some of the genes involved in the disorder. The neuroanatomical substrate of ADHD is becoming increasingly better defined by a growing body of evidence from imaging studies. Evidence from neuroimaging studies suggests that this disorder is associated with reductions in brain volume up to 5% in these children. In this protocol we collected MRI-scans from boys with ADHD and their unaffected siblings, as well as control subjects. In addition, cheekswabs were later collected for DNA analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- age 7 - 18 years.
- DSM-IV (APA, 1994) diagnosis of ADHD (combined subtype), according to DISC interview
- scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
- one brother who meets the inclusion criteria for siblings
- no DSM-IV (APA,1994) diagnosis for ADHD or another disruptive disorder (ODD or CD), according to DISC interview
Key exclusion criteria (3 listed)
- IQ < 70
- illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
- the presence of metal objects in or around the body (pacemaker, dental braces)
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2005.
- Results publication: PubMed 15076267Durston S, Hulshoff Pol HE, Schnack HG, Buitelaar JK, Steenhuis MP, Minderaa RB, Kahn RS, van Engeland H. Magnetic resonance imaging of boys with attention-deficit/hyperactivity disorder and their unaffected siblings. J Am Acad Child Adolesc Psychiatry. 2004 Mar;43(3):332-40. doi: 10.1097/00004583-200403000-00016.
- Results publication: PubMed 15724142Durston S, Fossella JA, Casey BJ, Hulshoff Pol HE, Galvan A, Schnack HG, Steenhuis MP, Minderaa RB, Buitelaar JK, Kahn RS, van Engeland H. Differential effects of DRD4 and DAT1 genotype on fronto-striatal gray matter volumes in a sample of subjects with attention deficit hyperactivity disorder, their unaffected siblings, and controls. Mol Psychiatry. 2005 Jul;10(7):678-85. doi: 10.1038/sj.mp.4001649.
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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
RMI of Neuroscience, UMC 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 30 Dec 2005. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00161161, which also lists 2 linked publications.
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 30 Dec 2005.