CompletedNot Applicable

Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate

United States84 participantsStarted 2005-12-07

Plain-language 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 checked. * Parents complete a questionnaire about the severity of the child's ADHD. * Parent and child describe the impact of symptoms on the child's 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 child's genetic material. * A physical examination is done to check child's health. * Information is provided parents to assist in planning for child's treatment after the study.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Children of either sex, and of any ethnicity and economic status, age 6-12 years inclusive, who are diagnosed with ADHD, who are drug na ve, and who are determined by the study psychiatrist to be appropriate candidates for pharmacological therapy with either Adderall or methylphenidate-based drugs. Child must be in good health as determined by medical history, physical examination and electrocardiogram (ECG). EXCLUSION CRITERIA: Children less than 6 years of age. Children more than 12 years of age. Children not determined to meet the comprehensive criteria for diagnosis of ADHD. Children with co-morbid psychological conditions that would containdicate treatment with stimulant drugs. Children who have previously undergone drug treatment for ADHD. Children who have received diagnostic x-rays (not dental x-rays) within the past 3 months. Female children who have had their first menstrual period. Subjects who are not competent to provide consents. Children determined by the study physician to be poor candidates for pharmacological therapy with Adderall or methylphenidate-based drugs. Children with clinically significant abnormal electrocardiogram (ECG).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00341029

SponsorNational Institute of Environmental Health Sciences (NIEHS)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2007-09-30

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials