Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341029
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention DeficitHyperactivity Disorder ADHD and Treated With Methylphenidate or Adderall
Status:
COMPLETED
Status Verified Date:
2009-06-26
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:
This study conducted at Duke University in Durham NC will determine whether the drugs Adderall and methylphenidate affect the genetic material of children with attention deficit hyperactivity disorder ADHD One small study has shown that taking methylphenidate for ADHD may result in higher levels of certain types of changes to the genetic material contained in white blood cells The changes seen are not directly linked to increased risk of disease but indicate a possibility that other kinds of damage that may be linked to increased disease may result from taking methylphenidate The study will also examine whether these types of changes might occur in children treated with Adderall
Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study Candidates are screened with a medical history psychiatric examination IQ test physical examination and electrocardiogram Parents and teachers complete questionnaires to rate the severity of the childs ADHD Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs eg Concerta Metadate Focalin Ritalin or Ritalin LA may be selected for this study
At a baseline visit Visit 0 parents complete questionnaires that rate the severity of their childs ADHD The children have their vital signs checked pulse blood pressure breathing rate height weight and temperature and have a blood sample drawn The children are then randomly assigned to treatment with either Adderall or a methylphenidate product After the baseline visit participants undergo the following tests and procedures
Dose Optimization Visits visits 1-4
In the first 4 weeks of the study the dose of methylphenidate or Adderall is adjusted weekly until doctors determine the dose strength that works best for the individual child In addition the following procedures are done at each visit
Childs vital signs are checked
Parents complete a questionnaire about the severity of the childs ADHD
Parent and child describe the impact of symptoms on the childs functioning
Parents complete forms about common side effects of the study drug
Follow-up Visits visits 5-6
Children return to the clinic once a month to assess their health and further adjust their medication dose if needed The visits are similar to those during the dose optimization period with the following additional procedures at visit 6
A blood sample is obtained to measure whether the medication has affected the childs genetic material
A physical examination is done to check childs health
Information is provided parents to assist in planning for childs treatment after the study
Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study Candidates are screened with a medical history psychiatric examination IQ test physical examination and electrocardiogram Parents and teachers complete questionnaires to rate the severity of the childs ADHD Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs eg Concerta Metadate Focalin Ritalin or Ritalin LA may be selected for this study
At a baseline visit Visit 0 parents complete questionnaires that rate the severity of their childs ADHD The children have their vital signs checked pulse blood pressure breathing rate height weight and temperature and have a blood sample drawn The children are then randomly assigned to treatment with either Adderall or a methylphenidate product After the baseline visit participants undergo the following tests and procedures
Dose Optimization Visits visits 1-4
In the first 4 weeks of the study the dose of methylphenidate or Adderall is adjusted weekly until doctors determine the dose strength that works best for the individual child In addition the following procedures are done at each visit
Childs vital signs are checked
Parents complete a questionnaire about the severity of the childs ADHD
Parent and child describe the impact of symptoms on the childs functioning
Parents complete forms about common side effects of the study drug
Follow-up Visits visits 5-6
Children return to the clinic once a month to assess their health and further adjust their medication dose if needed The visits are similar to those during the dose optimization period with the following additional procedures at visit 6
A blood sample is obtained to measure whether the medication has affected the childs genetic material
A physical examination is done to check childs health
Information is provided parents to assist in planning for childs treatment after the study
Detailed Description:
Design Longitudinal observational study of pediatric ADHD patients any subtype This study is part of a large comprehensive investigation initiated and funded by the National Institute of Child Health and Human Development to aid in the understanding of a reported association of methylphenidate treatment and elevated frequencies of some types of chromosome damage
Population 60 diagnosed ADHD children age range 6-12 years inclusive for whom pharmacological treatment with stimulant medication is indicated 30 children will initiate treatment with a methylphenidate-based product and 30 will initiate treatment with Adderall or Adderall-XR Study group assignment will be randomized as these two drugs are considered by the clinical community to be fully interchangeable
Primary Objective To determine the frequency of micronuclei markers of numerical or structural chromosomal damage sister chromatid exchanges indicators of DNA damage and chromosomal aberrations in lymphocytes of pediatric ADHD patients prior to and after 3 months of uninterrupted drug therapy These endpoints and the time frame are compatible with investigating effects during the initiation phase of treatment additional studies by other NIH institutes NIMH CDC will investigate effects after chronic treatment with stimulant medications so that a comprehensive picture of the potential for treatment-induced chromosomal damage in ADHD subjects is obtained
Secondary Objective In pediatric ADHD patients treated with a methylphenidate-based product or Adderall to determine if flow cytometric measurement of the frequency of micronucleated erythrocytes can serve as a biomarker of cytogenetic damage in lymphocytes evaluated by standard light microscope techniques
Population 60 diagnosed ADHD children age range 6-12 years inclusive for whom pharmacological treatment with stimulant medication is indicated 30 children will initiate treatment with a methylphenidate-based product and 30 will initiate treatment with Adderall or Adderall-XR Study group assignment will be randomized as these two drugs are considered by the clinical community to be fully interchangeable
Primary Objective To determine the frequency of micronuclei markers of numerical or structural chromosomal damage sister chromatid exchanges indicators of DNA damage and chromosomal aberrations in lymphocytes of pediatric ADHD patients prior to and after 3 months of uninterrupted drug therapy These endpoints and the time frame are compatible with investigating effects during the initiation phase of treatment additional studies by other NIH institutes NIMH CDC will investigate effects after chronic treatment with stimulant medications so that a comprehensive picture of the potential for treatment-induced chromosomal damage in ADHD subjects is obtained
Secondary Objective In pediatric ADHD patients treated with a methylphenidate-based product or Adderall to determine if flow cytometric measurement of the frequency of micronucleated erythrocytes can serve as a biomarker of cytogenetic damage in lymphocytes evaluated by standard light microscope techniques
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-E-N045 | None | None | None |