Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483106
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2007-06-04
Brief Title:
Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder ADHD
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2021-03
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 with hyperactivity disorder ADHD is a very common behavioral problem during childhood It is estimated that up to 80 of this disorder could be related to genetic factors The most common treatment for ADHD is psychostimulants In this study the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate Response to methylphenidate is evaluated through a double blind placebo controlled one week study
Detailed Description:
Attention Deficit Hyperactivity disorder ADHD is a syndrome that is characterized by inattention motor hyperactivity and impulsivity It affects 8 to 12 of the population The presentation of children with ADHD can be varied from simple inattention to severe motor hyperactivity and impulsivity It has a negative impact on the childs life including poor school achievement and difficulty with peer and family relationships
Although the etiology of ADHD is not well understood genetic factors are known to play a significant role in the pathogenesis of ADHD as indicated by family twin and adoption studies In addition environmental factors such as smoking during pregnancy and obstetrical complications have been found to contribute significantly in increasing the risk for and severity of ADHD It is therefore likely that genetic predisposing factors interact with environmental factors to produce the behavioral disturbances observed in ADHD The first goal of this study is therefore to investigate possible genetic and environmental risk factors and examine how they might interact to confer increased risk for ADHD
A majority of children 70 with ADHD show a significant improvement with of their behavioral disorder when treated with stimulant drugs such as methylphenidate MPH However the extent to which each child benefits from MPH is variable and some of the children do not improve at all in spite of adequate trials with stimulant drugs The second purpose of this project is to study the correlatespredictors of responsiveness to MPH in school-aged children and to identify genetic factors that may modulate the behavioral response to this drug
In order to achieve our research goals children with ADHD are invited to participate to a two-week double-blind placebo controlled medication trial with MPH Ritalin 05mgkgday During these two weeks neuropsychological and behavioral assessments of the child are performed at the clinic to evaluate the cognitive performance of the child while on medication and placebo Parents are invited to answer questionnaires about the behavior of their child and about family history of mental disorders as well as prenatal and perinatal risk factors Finally the participating child both parents and siblings are invited to provide a blood or saliva sample for genetic analysis
Although the etiology of ADHD is not well understood genetic factors are known to play a significant role in the pathogenesis of ADHD as indicated by family twin and adoption studies In addition environmental factors such as smoking during pregnancy and obstetrical complications have been found to contribute significantly in increasing the risk for and severity of ADHD It is therefore likely that genetic predisposing factors interact with environmental factors to produce the behavioral disturbances observed in ADHD The first goal of this study is therefore to investigate possible genetic and environmental risk factors and examine how they might interact to confer increased risk for ADHD
A majority of children 70 with ADHD show a significant improvement with of their behavioral disorder when treated with stimulant drugs such as methylphenidate MPH However the extent to which each child benefits from MPH is variable and some of the children do not improve at all in spite of adequate trials with stimulant drugs The second purpose of this project is to study the correlatespredictors of responsiveness to MPH in school-aged children and to identify genetic factors that may modulate the behavioral response to this drug
In order to achieve our research goals children with ADHD are invited to participate to a two-week double-blind placebo controlled medication trial with MPH Ritalin 05mgkgday During these two weeks neuropsychological and behavioral assessments of the child are performed at the clinic to evaluate the cognitive performance of the child while on medication and placebo Parents are invited to answer questionnaires about the behavior of their child and about family history of mental disorders as well as prenatal and perinatal risk factors Finally the participating child both parents and siblings are invited to provide a blood or saliva sample for genetic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None