NCT00341029

Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate

Completed Last updated 2 July 2017

What this trial tests

trial in Attention Deficit Hyperactivity Disorder in 84 participants. Completed in 30 September 2007.

Timeline

7 December 2005

Primary endpoint
30 September 2007

30 September 2007

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	84
Start date	7 December 2005
Primary completion	30 September 2007
Estimated completion	30 September 2007
Sites	1 location across United States

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
• ADHD — all drugs for ADHD →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 6 to 12, any sex, with Attention Deficit Hyperactivity Disorder or ADHD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD.
   Witt KL, Shelby MD, Itchon-Ramos N, Faircloth M, et al · · 2008 · cited 21× · PMID 18978633 · DOI 10.1097/chi.0b013e3181893620