Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046059
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2002-09-18
Brief Title:
Genetic Analysis of Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genetic Analysis of Attention Deficit Hyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2024-07-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 4q132
In order to provide power for the study s statistical analyses the upper enrollment goal is 4000 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
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 4q132
In order to provide power for the study s statistical analyses the upper enrollment goal is 4000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-HG-0058 | None | None | None |