Attention Deficit Disorder With HyperactivityNCT01721720
Genetic, Brain Structure, and Environmental Effects on ADHD
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable of all neuropsychiatric disorders. It causes problems with attention and impulse control. However, the genetic component of ADHD has not been fully studied, including how genes interact with the environment. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 1,091 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2012to 25 Jul 2024
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children, adolescents, and adults with Attention Deficit Hyperactivity Disorder and healthy controls. Some participants will be from families that have many individuals affected by ADHD.
Who may be able to join
- Three or more years of age with no upper limit for age at time of enrollment. The lower limit of 3 years of age is chosen as it is difficult to diagnose ADHD below this age, but the diagnosis can be reliably made from age 3 onwards. As this study examines the developmental trajectories of ADHD into adulthood, no upper age limit has been set.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) defined ADHD. The DSM-IV diagnosis of ADHD will be based on the Parent Diagnostic Interview for Children and Adolescents in participants 18 years or age and younger and the
- Structured clinical interview for the Diagnosis of DSM Disorders for participants above 18 years of age. We include all forms of ADHD in DSM-5 (i.e. combined, predominately hyperactive/impulsive, predominately inattentive and other specified presentations). ADHD is rarely found in isolation and comorbidity is common. Thus the protocol will include individuals with ADHD and the
- following disorders: oppositional defiant disorder, conduct disorder, anxiety disorders (generalized anxiety, specific phobias), tic disorders, mood disorders (dysthymia, depression); specific learning disabilities and disruptive mood dysregulation disorder.
- We will also include families where there is a incidence of >30% of ADHD in first, second and third degree relatives. This level is chosen as it is well above the incidence rate of ADHD in the general population (~5-7%). Additional inclusion criteria are families where the proband has at least one sibling and only one or neither parent is affected.
- In studying the acute effects of treatment we will include all participants with ADHD who are starting psychostimulant medications for the first time (all psychostimulant preparations are included). We will also include participants with ADHD who are receiving behavioral
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- management for ADHD for the first time.
- INCLUSIONS CRITERIA FOR THE FAMILY STUDY:
- We will also include families where there is a incidence of >30% of ADHD in first, second and third degree relatives. This level is chosen as it is well above the incidence rate of ADHD in the general population (~5-7%). Additional inclusion criteria are families where the proband has at least one sibling and only one or neither parent is affected.
- We have already identified families of our currently enrolled probands in which at least 4 other first, second or third degree relatives have a current diagnosis of ADHD or had this diagnosis in childhood (and have a similar number of unaffected relatives). We will recruit further families with a similar density of individual affected by ADHD.
Who cannot join
- Full scale IQ of less than 70. Below this level a child is considered to have global intellectual disability (classified in DSM-IVR as mental retardation). By definition this means the individual cannot be considered to be a healthy control . While many individual with IQ below 70 have symptoms of ADHD, the diagnosis is complicated by problems in assessing attentional abilities.
- Finally, there are often issues around the ability to give informed consent in adults with global intellectual disability.
- Birth before 32 weeks of gestation. Premature birth can have a profound effect on brain function and structure.
- Presence or history of medical conditions known to affect cerebral anatomy (eg epilepsy, history of stroke). Genetic syndromes which are associated with well-established alterations of gross cerebral structure- such as NF1, tuberous sclerosis and some forms of epilepsy. Children with known microdeletion syndromes will not be excluded provided (1) the syndrome is not known to be associated with alteration of cerebral anatomy (detectable on current clinical MRI sequences) and (2) other exclusionary criteria do not apply such as global intellectual impairment (defined in this protocol as IQ above 70). Data from these individuals with microdeletion syndromes will
- not however be included in GWAS due to analytic complications.
- Dental braces (as these distort the MRI image). Metal in the body or other contraindications for MRI scanning. For females who have reached menarche and have not yet past menopause: pregnancy or inability or unwillingness to undergo pregnancy testing (for MRI
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- safety).
- For participants 60 years or older. Folstein mini mental state examination score of 26 or greater. This is a widely accepted screening test for dementia.
- ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS ONLY: Presence of any DSM-IV psychiatric disorder in the subject or current use of psychiatric medication.
- ADDITIONAL EXCLUSION CRITERIA FOR THE CLINICAL POPULATION ONLY:
- Some neuropsychiatric disorders are either so rare or associated with such profound alterations of brains structure and function that they will be excluded. This includes psychotic disorders (including schizophrenia, psychosis NOS) bipolar affective disorder; autism, substance dependence; dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Neurobehavioral, Environmental and Genetic Factors Impacting the Clinical Course of Attention Deficit Hyperactivity Disorder
Background:
- Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable of all neuropsychiatric disorders. It causes problems with attention and impulse control. However, the genetic component of ADHD has not been fully studied, including how genes interact with the environment. Researchers want to study children and adults who have ADHD. They will look at how genetic, brain structure, and environmental factors affect ADHD in children and adults.
Read more
Objectives:
- To study genetic, brain structure, and environmental factors in ADHD in children and adults.
Eligibility:
- Individuals at least 3 years of age who have ADHD.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will be interviewed about their ADHD. They will also complete behavior and psychological tests. Parents or guardians will complete the tests along with participants under 18 years of age.
- Participants will provide saliva or blood samples.
- Participants will also have imaging studies of the brain.
- Participants under 25 years of age will return once a year to repeat the tests. Those over 25 years of age will have only the one set of tests. Those who are starting stimulant drugs and who are receiving behavioral treatment for the first time will also have another set of tests 12 weeks after the start of treatment.
Read the detailed description
OBJECTIVES:
This study aims to provide novel phenotypes for genomic studies into Attention- Deficit Hyperactivity Disorder (ADHD), one of the most common and heritable of all neuropsychiatric disorders. It proposes to split the disorder into neurobiologically more meaningful entities by delineating subgroups based on neurobehavioral profiles. It will also explore factors that impact clinical course, focusing on the neural effects of treatment and the role of the child s social environment.
POPULATION AND DESIGN:
Using a prospective longitudinal design, a group of children and adolescents with ADHD will be followed. Additionally, families that have several members affected by ADHD will be recruited.
OUTCOMES:
The study will link the onset and clinical course of ADHD with genotype, brain structure and function, behavior and the child s social environment.
- Keywords
- Peer and Family Networks, Longitudinal Outcome, MRI Imaging, Genetics, Childhood Psychiatric Disorders, Natural History
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with and without ADHD | Participants with and without ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain MRI
Trajectories of brain development
Measured: yearly or at the participant's availability
Secondary outcomes (1)
DNA collection, clinical interviews, social network information gathering
To explore the neural, genomic and socio-environmental factors that determine the course of ADHD
Measured: yearly or at the participant's convenience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study start9 Nov 2012
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wallace P Shaw, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721720
- Sponsor's protocol ID
- 120202
- Other IDs
- 12-HG-0202
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2012
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified medical information will be placed in a NIH repository (e.g., Biomedical Translational Research Information System (BTRIS)) in accordance to NIH policies. We will also share genomic and phenotypic data in controlled access databases such as dbGAP (database of Genotypes and Phenotypes). Other databases may be used as approved by NIH for the sharing of de-identified data.
Publications
Sudre G, Norman L, Bouyssi-Kobar M, Price J, Shastri GG, Shaw P. A Mega-analytic Study of White Matter Microstructural Differences Across 5 Cohorts of Youths With Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry. 2023 Jul 1;94(1):18-28. doi: 10.1016/j.biopsych.2022.09.021. Epub 2022 Sep 26.
PubMed 36609028
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurobehavioral, Environmental and Genetic Factors Impacting the Clinical Course of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01721720
- Acronym / sponsor ID
- 120202
- Keywords
- Peer and Family Networks, Longitudinal Outcome, MRI Imaging, Genetics, Childhood Psychiatric Disorders, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,091 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 9 Nov 2012 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 6 Nov 2012 (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.
Background:
- Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable of all neuropsychiatric disorders. It causes problems with attention and impulse control. However, the genetic component of ADHD has not been fully studied, including how genes interact with the environment. Researchers want to study children and adults who have ADHD. They will look at how genetic, brain structure, and environmental factors affect ADHD in children and adults.
Objectives:
- To study genetic, brain structure, and environmental factors in ADHD in children and adults.
Eligibility:
- Individuals at least 3 years of age who have ADHD.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will be interviewed about their ADHD. They will also complete behavior and psychological tests. Parents or guardians will complete the tests along with participants under 18 years of age.
- Participants will provide saliva or blood samples.
- Participants will also have imaging studies of the brain.
- Participants under 25 years of age will return once a year to repeat the tests. Those over 25 years of age will have only the one set of tests. Those who are starting stimulant drugs and who are receiving behavioral treatment for the first time will also have another set of tests 12 weeks after the start of treatment.
Detailed description
OBJECTIVES:
This study aims to provide novel phenotypes for genomic studies into Attention- Deficit Hyperactivity Disorder (ADHD), one of the most common and heritable of all neuropsychiatric disorders. It proposes to split the disorder into neurobiologically more meaningful entities by delineating subgroups based on neurobehavioral profiles. It will also explore factors that impact clinical course, focusing on the neural effects of treatment and the role of the child s social environment.
POPULATION AND DESIGN:
Using a prospective longitudinal design, a group of children and adolescents with ADHD will be followed. Additionally, families that have several members affected by ADHD will be recruited.
OUTCOMES:
The study will link the onset and clinical course of ADHD with genotype, brain structure and function, behavior and the child s social environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with and without ADHD | – | –Participants with and without ADHD |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, adolescents, and adults with Attention Deficit Hyperactivity Disorder and healthy controls. Some participants will be from families that have many individuals affected by ADHD.
Key inclusion criteria (10 listed)
- Three or more years of age with no upper limit for age at time of enrollment. The lower limit of 3 years of age is chosen as it is difficult to diagnose ADHD below this age, but the diagnosis can be reliably made from age 3 onwards. As this study examines the developmental trajectories of ADHD into adulthood, no upper age limit has been set.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) defined ADHD. The DSM-IV diagnosis of ADHD will be based on the Parent Diagnostic Interview for Children and Adolescents in participants 18 years or age and younger and the
- Structured clinical interview for the Diagnosis of DSM Disorders for participants above 18 years of age. We include all forms of ADHD in DSM-5 (i.e. combined, predominately hyperactive/impulsive, predominately inattentive and other specified presentations). ADHD is rarely found in isolation and comorbidity is common. Thus the protocol will include individuals with ADHD and the
- following disorders: oppositional defiant disorder, conduct disorder, anxiety disorders (generalized anxiety, specific phobias), tic disorders, mood disorders (dysthymia, depression); specific learning disabilities and disruptive mood dysregulation disorder.
- We will also include families where there is a incidence of >30% of ADHD in first, second and third degree relatives. This level is chosen as it is well above the incidence rate of ADHD in the general population (~5-7%). Additional inclusion criteria are families where the proband has at least one sibling and only one or neither parent is affected.
Key exclusion criteria (11 listed)
- Full scale IQ of less than 70. Below this level a child is considered to have global intellectual disability (classified in DSM-IVR as mental retardation). By definition this means the individual cannot be considered to be a healthy control . While many individual with IQ below 70 have symptoms of ADHD, the diagnosis is complicated by problems in assessing attentional abilities.
- Finally, there are often issues around the ability to give informed consent in adults with global intellectual disability.
- Birth before 32 weeks of gestation. Premature birth can have a profound effect on brain function and structure.
- Presence or history of medical conditions known to affect cerebral anatomy (eg epilepsy, history of stroke). Genetic syndromes which are associated with well-established alterations of gross cerebral structure- such as NF1, tuberous sclerosis and some forms of epilepsy. Children with known microdeletion syndromes will not be excluded provided (1) the syndrome is not known to be associated with alteration of cerebral anatomy (detectable on current clinical MRI sequences) and (2) other exclusionary criteria do not apply such as global intellectual impairment (defined in this protocol as IQ above 70). Data from these individuals with microdeletion syndromes will
- not however be included in GWAS due to analytic complications.
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
Brain MRI
Time frame: yearly or at the participant's availability
Trajectories of brain development
1 secondary outcome
DNA collection, clinical interviews, social network information gathering
Time frame: yearly or at the participant's convenience
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 16 Oct 2024.
- Derived from this study: PubMed 36609028Sudre G, Norman L, Bouyssi-Kobar M, Price J, Shastri GG, Shaw P. A Mega-analytic Study of White Matter Microstructural Differences Across 5 Cohorts of Youths With Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry. 2023 Jul 1;94(1):18-28. doi: 10.1016/j.biopsych.2022.09.021. Epub 2022 Sep 26.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified medical information will be placed in a NIH repository (e.g., Biomedical Translational Research Information System (BTRIS)) in accordance to NIH policies. We will also share genomic and phenotypic data in controlled access databases such as dbGAP (database of Genotypes and Phenotypes). Other databases may be used as approved by NIH for the sharing of de-identified data.
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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.
Wallace P Shaw, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
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 Disorder With Hyperactivity, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
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 10 inclusion and 11 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 16 Oct 2024. 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 United States. 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.
What does the primary outcome measure?
Brain MRI (time frame: yearly or at the participant's availability). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721720, which also lists 1 linked publication.
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 16 Oct 2024.