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NCT00341029 · ClinicalTrials.gov registry record
Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 84
- Enrollment target
NCT00341029: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00341029 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 84 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341029 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 84 participants
- Enrollment target
Study 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 child's ADHD. Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs (e.g., 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 child's 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: * Child's vital signs are chec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2005-12-07 |
| Est. Completion | 2007-09-30 |
What the finished NCT00341029 record still lists
NCT00341029 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 84 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00341029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341029 about?
NCT00341029 is a clinical study titled "Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate". 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 leve...
What is the current status of trial NCT00341029?
This trial is currently completed. The enrollment target is 84 participants. The study started on 2005-12-07. Estimated completion is 2007-09-30.
Who is sponsoring clinical trial NCT00341029?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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