Attention Deficit Hyperactivity DisorderNCT00341029
Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate
An observational study of Attention Deficit Hyperactivity Disorder and ADHD, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, ADHD
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2005to 30 Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall
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.
Read more
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, ADHD
- Keywords
- Longitudinal Study, Chromosomal Effects, Sister Chromatid Exchanges, Micronuclei, Stimulants, Attention Deficit Hyperactivity Disorder, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 Dec 2005
- Primary completion30 Sep 2007
- Study completion30 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341029
- Sponsor's protocol ID
- 999906045
- Other IDs
- 06-E-N045
- Status last verified
- 26 Jun 2009
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 10749131Bonassi 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.
PubMed 15688363Dertinger 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.
PubMed 11909751Witt 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.
PubMed 18978633
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall
- ClinicalTrials.gov ID
- NCT00341029
- Acronym / sponsor ID
- 999906045
- Conditions
- Attention Deficit Hyperactivity Disorder, ADHD
- Keywords
- Longitudinal Study, Chromosomal Effects, Sister Chromatid Exchanges, Micronuclei, Stimulants, Attention Deficit Hyperactivity Disorder, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 7 Dec 2005
- Primary completion
- 30 Sep 2007 (actual)
- Study completion
- 30 Sep 2007 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10749131Bonassi 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.
- Background: PubMed 15688363Bonassi 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.
- Background: PubMed 11909751Dertinger 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.
- Derived from this study: PubMed 18978633Witt 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.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and ADHD, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341029, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.