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Effects of Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity P.I. Judith L. Rapoport M.D. Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): a Functional Magnetic Resonance Imaging Study. Background.

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  1. Effects of Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity P.I. Judith L. Rapoport M.D.

  2. Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): a Functional Magnetic Resonance Imaging Study

  3. Background • Attention Deficit Hyperactivity Disorder • Most common childhood behavioral disorder (approximately 5% of children) • Core symptoms: • Difficulty paying attention, staying on task • Impulsive behavior • Extreme physical restlessness • Cause is unknown, clear genetic influence

  4. Background (cont.) • Attention Deficit Hyperactivity Disorder • Stimulants are the treatment of choice • Treatment decisions based on clinical opinion • Public health concerns about the high rate of stimulant use • Inconsistencies in prescribing practices across physicians • Strong need for neuroscience-based diagnostic, treatment, and outcome measures

  5. Primary Scientific Questions • Do children with ADHD have a different central nervous system (CNS) response to stimulants (i.e., activation of fronto-striatal brain regions) compared to children without ADHD? • Do genetic determinants or clinical characteristics predict CNS responses and activation patterns to stimulants?

  6. Scientific Value • To see whether CNS response to stimulants differs for children with ADHD versus healthy children volunteers. • If the response differs, to see whether this is due to genetic factors or to state of distractibility. • Could provide fundamental information about the pathophysiology of ADHD and the effects of treatment.

  7. Protocol: subjects • 14 Children with ADHD • 24 Monozygotic twins discordant for ADHD • 24 Dizygotic twins discordant for ADHD • 14 Healthy control children • Age range for all children: 9-18 years

  8. Protocol: procedures • History and physical examination • Blood work (including genetic testing) • Neuropsychological testing • Placebo-controlled, double-blinded administration of a single dose of dextroamphetamine (10 mg oral dose) • Single functional MRI session (1-1.5 hrs) • Subjects to be paid $ 570 (11 hrs total)

  9. IRB Concerns • The primary IRB concern was about the risk level of the study for healthy children and whether the administration of a psychostimulant to these children (for whom there is no potential for medical benefit) was approvable under the federal regulations. • Does risk vary according to the age of the child? • Questions were also raised about the scientific value of the study (despite very strong science reviews) • Potential undue influence of payment

  10. Non-beneficial Pediatric Research • The Federal Regulations allow IRBs to approve non-beneficial pediatric research provided the risks are no greater than minimal, defined as “the risks of daily life.”

  11. Non-beneficial Pediatric Research • The Federal Regulations allow IRBs to approve non-beneficial pediatric research provided the risks are no greater than minimal, defined as “the risks of daily life.” • The regulations also allow IRBs to approve non-beneficial pediatric research provided that the study poses a “minor increment over minimal risk” and will yield “generalizable knowledge about the subject’s disorder or condition.”

  12. Non-beneficial Pediatric Research • The Federal Regulations allow IRBs to approve non-beneficial pediatric research provided the risks are no greater than minimal, defined as “the risks of daily life.” • The regulations also allow IRBs to approve non-beneficial pediatric research provided that the study poses a “minor increment over minimal risk” and will yield “generalizable knowledge about the subject’s disorder or condition.” • Non-beneficial research that poses more than a minor increment over minimal risk requires approval from DHHS (45 CFR 46.407 “panel”)

  13. Risks of Study • Evaluation • Genetic testing • fMRI • Administration of dextroamphetamine • Loss of appetite • Nervousness • Insomnia • Future substance abuse?

  14. Stimulant Use in Children • Risk of subsequent substance abuse • 3 of 4 studies of long-term (months/years) stimulant treatment of patients with ADHD found no increased risk of future substance abuse • No data are available relevant to risks associated with a single dose of a stimulant in healthy children

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