Status:
COMPLETED
Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Attention Deficit Hyperactivity Disorder
ADHD
Eligibility:
All Genders
6-12 years
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 disor...
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 Heal...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
December 7 2005
Trial Type :
OBSERVATIONAL
End Date :
September 30 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00341029
Start Date
December 7 2005
End Date
September 30 2007
Last Update
July 2 2017
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710