Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate

NCT00341029 | Completed

• 2 other identifiers: 99990604506-E-N045
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Attention Deficit Hyperactivity Disorder; ADHD

Keywords

Longitudinal Study; Chromosomal Effects; Sister Chromatid Exchanges; Micronuclei; Stimulants; Attention Deficit Hyperactivity Disorder; ADHD

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• Bonassi S, Hagmar L, Stromberg U, Montagud AH, Tinnerberg H, Forni A, Heikkila P, Wanders S, Wilhardt P, Hansteen IL, Knudsen LE, Norppa H. Chromosomal aberrations in lymphocytes predict human cancer independently of exposure to carcinogens. European Study Group on Cytogenetic Biomarkers and Health. Cancer Res. 2000 Mar 15;60(6):1619-25.

  PMID: 10749131 BACKGROUND

• Bonassi S, Ugolini D, Kirsch-Volders M, Stromberg U, Vermeulen R, Tucker JD. Human population studies with cytogenetic biomarkers: review of the literature and future prospectives. Environ Mol Mutagen. 2005 Mar-Apr;45(2-3):258-70. doi: 10.1002/em.20115.

  PMID: 15688363 BACKGROUND

• Dertinger SD, Torous DK, Hall NE, Murante FG, Gleason SE, Miller RK, Tometsko CR. Enumeration of micronucleated CD71-positive human reticulocytes with a single-laser flow cytometer. Mutat Res. 2002 Mar 25;515(1-2):3-14. doi: 10.1016/s1383-5718(02)00009-8.

  PMID: 11909751 BACKGROUND

• Witt KL, Shelby MD, Itchon-Ramos N, Faircloth M, Kissling GE, Chrisman AK, Ravi H, Murli H, Mattison DR, Kollins SH. Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1375-83. doi: 10.1097/CHI.0b013e3181893620.

  PMID: 18978633 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 7, 2005
• Primary Completion: September 30, 2007
• Study Completion: September 30, 2007
• Last Updated: July 2, 2017

Record last verified: 2009-06-26

Locations

US (1)