ADHDNCT00046059
Genetic Analysis of Attention Deficit Hyperactivity Disorder (ADHD)
An observational study of ADHD, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder in childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest that there is a genetic component to ADHD. Scientists believe that it is a complex disorder in which two or more genes may be involved. Read more about this study
- Who is it for?
- Ages 7 to 110 years
- Conditions the study is for
- ADHD
- How many people
- 3,481 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Feb 2000to 24 Jan 2020
- 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 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study). 2. The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings. 3. The parents, both mothers and fathers, of enrolled probands.
Who may be able to join
- This study will enroll families with the following characteristics:
- Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study).
- The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings.
- The parents, both mothers and fathers, of enrolled probands.
- The study will enroll both male and female probands of any ethnic background and race. The prevalence of ADHD is higher in males than in females, so we would expect to have a higher number of male probands than female probands. Both male and female siblings and male and female parents of probands will be enrolled.
- Adults who are or may be unable to provide informed consent will be excluded.
Show all 9Show fewer
- Probands with one parent affected with ADHD or with neither parent affected with ADHD are eligible. Probands from bilineal families, families with both parents affected with ADHD, will be excluded for statistical reasons.
- Additional inclusion criteria for the study include:
- 1. Ability to read and understand spoken English, since the questionnaires, scales, and interviews that we have license to use in this study are in English.
Who cannot join
- Some conditions can confound the diagnosis of ADHD. Probands with the following conditions will be excluded from enrollment or will be withdrawn from the study if the condition is discovered subsequent to enrollment:
- Prematurity
- Neurological conditions
- Cardiac surgery
- Prenatal drug exposure
- Hydrocephaly
Show all 27Show fewer
- Mental Retardation (IQ<80)
- Known genetic syndromes
- Known CNS disorders
- Known lead toxicity
- Tourette Disorder
- Obsessive-Compulsive Disorder
- Major Depression on both proband and affected sibling
- Pervasive Developmental Disorder
- Age under 7 years old
- Autism
- Other Psychoses
- Post Traumatic Stress Disorder
- Language Disorder (if known)
- Severe Sensory Impairment (visual and hearing)
- Probands with the following conditions may be included, but the conditions will be noted during statistical analysis:
- Oppositional Defiant Disorder
- Conduct Disorder
- Tic Disorder
- Obsessive/Compulsive Symptoms
- Anxiety/Phobias
- Learning Disabilities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of California, Irvine Medical Center
Orange, California, 92668
About this study
Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder in childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest that there is a genetic component to ADHD. Scientists believe that it is a complex disorder in which two or more genes may be involved.
Potentially eligible families will be asked to give written consent to participate and will be asked to complete questionnaires for each member in the family. In addition, an interview will be administered to the parent of minors enrolled in the study to determine their eligibility for being in the study. This screening tool is computerized and will take approximately 45 minutes to administer per child.
Once screenings are completed, a blood collection kit will be sent to the family to take to their local medical care provider, have blood samples drawn and sent to NIH. There is no cost to the family to participate. We would like to enroll entire families, with both parents and all children.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common childhood
disorders and the most common childhood neurodevelopmental behavioral disorder. Symptoms include difficulty staying focused (inattention), difficulty controlling behavior (impulsivity), and hyperactivity. Symptoms typically develop between six and 12 years of age, and frequently persist into adulthood, with serious life-long health and social consequences. Affected children are at increased risk for poor educational achievement, low income, underemployment, legal difficulties, and impaired social relationships. The general belief is that ADHD is caused by a combination of genetic and environmental factors.
The main objective of the study is to conduct genetic and behavioral studies that will closely
characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological
response in ADHD patients. Since the start of the study in 2000, research has contributed to the understanding of the innate susceptibility of ADHD and associated comorbidities; the interaction of genetic, demographic, and environmental factors underpinning the risk of developing ADHD; the extent to which these factors shape the response of ADHD patients to pharmacological interventions (pharmacogenetics); the over-representation of functional and ontological genebased networks implicated in determining synapse structure; and the use of advanced geneticepidemiological models with potential for use in clinical practice (translational genomics). The most significant research finding occurred in 2010, when the study team identified LPHN3, a key gene involved in the etiology of ADHD and comorbid conditions in one of the previously identified regions of strong genetic signal in chromosome 4q13.2.
In order to provide power for the study s statistical analyses, the upper enrollment goal is 4,000 participants. Although the study has several small and genetically distinct cohorts, the majority of subjects come from the United States of America population through outreach recruitment efforts. Recruitment has been very successful and the large cohort numbers provide support for identification of genetic components related to the diagnosis of ADHD. Recent efforts have focused on identifying new areas of the genome associated with ADHD, and identifying genetic (coding and non-coding) variations implicated in the etiology and clinical manifestations of ADHD. A primary aim of the study is to correlate genetic and biological markers for diagnosis and prognosis of ADHD identified through the use of state of the art genomics, which includes enome-wide association studies, linkage analysis, whole genome and exome sequencing, and targeted gene capture in cosmopolitan and isolated populations. As the current diagnosis of ADHD is based on subjective observations, one of the main goals of the study is to develop a more definitive system to diagnose ADHD and to assess and predict prognosis.
- Conditions
- ADHD
- Keywords
- Linkage, Gene Identification, Hyperactivity, Natural History, Attention Deficit Hyperactivity Disorder, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
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 |
|---|---|---|
| ADHD | Children aged 7-17 with ADHD and their families. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD
The main objective of the study is to conduct genetic and behavioral studies that will closely characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological response in ADHD patients.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2002 (estimated)
- Study start8 Feb 2000
- Primary completion30 Jan 2019
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maria T Acosta, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046059
- Sponsor's protocol ID
- 000058
- Other IDs
- 00-HG-0058
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2002
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: pending
Publications
Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.
PubMed 2432848Biederman J, Faraone S, Milberger S, Guite J, Mick E, Chen L, Mennin D, Marrs A, Ouellette C, Moore P, Spencer T, Norman D, Wilens T, Kraus I, Perrin J. A prospective 4-year follow-up study of attention-deficit hyperactivity and related disorders. Arch Gen Psychiatry. 1996 May;53(5):437-46. doi: 10.1001/archpsyc.1996.01830050073012.
PubMed 8624187Faraone SV, Biederman J, Chen WJ, Milberger S, Warburton R, Tsuang MT. Genetic heterogeneity in attention-deficit hyperactivity disorder (ADHD): gender, psychiatric comorbidity, and maternal ADHD. J Abnorm Psychol. 1995 May;104(2):334-345. doi: 10.1037/0021-843X.104.2.334.
PubMed 7790635
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00046059
- Acronym / sponsor ID
- 000058
- Conditions
- ADHD
- Keywords
- Linkage, Gene Identification, Hyperactivity, Natural History, Attention Deficit Hyperactivity Disorder, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,481 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 8 Feb 2000 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 19 Sep 2002 (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 the most common behavioral disorder in childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest that there is a genetic component to ADHD. Scientists believe that it is a complex disorder in which two or more genes may be involved.
Potentially eligible families will be asked to give written consent to participate and will be asked to complete questionnaires for each member in the family. In addition, an interview will be administered to the parent of minors enrolled in the study to determine their eligibility for being in the study. This screening tool is computerized and will take approximately 45 minutes to administer per child.
Once screenings are completed, a blood collection kit will be sent to the family to take to their local medical care provider, have blood samples drawn and sent to NIH. There is no cost to the family to participate. We would like to enroll entire families, with both parents and all children.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common childhood
disorders and the most common childhood neurodevelopmental behavioral disorder. Symptoms include difficulty staying focused (inattention), difficulty controlling behavior (impulsivity), and hyperactivity. Symptoms typically develop between six and 12 years of age, and frequently persist into adulthood, with serious life-long health and social consequences. Affected children are at increased risk for poor educational achievement, low income, underemployment, legal difficulties, and impaired social relationships. The general belief is that ADHD is caused by a combination of genetic and environmental factors.
The main objective of the study is to conduct genetic and behavioral studies that will closely
characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological
response in ADHD patients. Since the start of the study in 2000, research has contributed to the understanding of the innate susceptibility of ADHD and associated comorbidities; the interaction of genetic, demographic, and environmental factors underpinning the risk of developing ADHD; the extent to which these factors shape the response of ADHD patients to pharmacological interventions (pharmacogenetics); the over-representation of functional and ontological genebased networks implicated in determining synapse structure; and the use of advanced geneticepidemiological models with potential for use in clinical practice (translational genomics). The most significant research finding occurred in 2010, when the study team identified LPHN3, a key gene involved in the etiology of ADHD and comorbid conditions in one of the previously identified regions of strong genetic signal in chromosome 4q13.2.
In order to provide power for the study s statistical analyses, the upper enrollment goal is 4,000 participants. Although the study has several small and genetically distinct cohorts, the majority of subjects come from the United States of America population through outreach recruitment efforts. Recruitment has been very successful and the large cohort numbers provide support for identification of genetic components related to the diagnosis of ADHD. Recent efforts have focused on identifying new areas of the genome associated with ADHD, and identifying genetic (coding and non-coding) variations implicated in the etiology and clinical manifestations of ADHD. A primary aim of the study is to correlate genetic and biological markers for diagnosis and prognosis of ADHD identified through the use of state of the art genomics, which includes enome-wide association studies, linkage analysis, whole genome and exome sequencing, and targeted gene capture in cosmopolitan and isolated populations. As the current diagnosis of ADHD is based on subjective observations, one of the main goals of the study is to develop a more definitive system to diagnose ADHD and to assess and predict prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | –Children aged 7-17 with ADHD and their families. |
Who may qualify
- Ages
- 7 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study). 2. The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings. 3. The parents, both mothers and fathers, of enrolled probands.
Key inclusion criteria (9 listed)
- Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study).
- The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings.
- The parents, both mothers and fathers, of enrolled probands.
- The study will enroll both male and female probands of any ethnic background and race. The prevalence of ADHD is higher in males than in females, so we would expect to have a higher number of male probands than female probands. Both male and female siblings and male and female parents of probands will be enrolled.
- Adults who are or may be unable to provide informed consent will be excluded.
Key exclusion criteria (27 listed)
- Some conditions can confound the diagnosis of ADHD. Probands with the following conditions will be excluded from enrollment or will be withdrawn from the study if the condition is discovered subsequent to enrollment:
- Prematurity
- Neurological conditions
- Cardiac surgery
- Prenatal drug exposure
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
ADHD
Time frame: Ongoing
The main objective of the study is to conduct genetic and behavioral studies that will closely characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological response in ADHD patients.
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 24 Dec 2024.
- Background: PubMed 2432848Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.
- Background: PubMed 8624187Biederman J, Faraone S, Milberger S, Guite J, Mick E, Chen L, Mennin D, Marrs A, Ouellette C, Moore P, Spencer T, Norman D, Wilens T, Kraus I, Perrin J. A prospective 4-year follow-up study of attention-deficit hyperactivity and related disorders. Arch Gen Psychiatry. 1996 May;53(5):437-46. doi: 10.1001/archpsyc.1996.01830050073012.
- Background: PubMed 7790635Faraone SV, Biederman J, Chen WJ, Milberger S, Warburton R, Tsuang MT. Genetic heterogeneity in attention-deficit hyperactivity disorder (ADHD): gender, psychiatric comorbidity, and maternal ADHD. J Abnorm Psychol. 1995 May;104(2):334-345. doi: 10.1037/0021-843X.104.2.334.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. pending
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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.
Maria T Acosta, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by National Human Genome Research Institute (NHGRI) at 2 sites 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 9 inclusion and 27 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
ADHD (time frame: Ongoing). 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 NCT00046059, which also lists 3 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 24 Dec 2024.