Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00483106 |
| Other study ID # |
99-22 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1999 |
| Est. completion date |
March 31, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 child's 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 correlates/predictors 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, 0.5mg/kg/day).
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.
