Office for Human Research Protections (OHRP)

Requesting IRB:

National Institute of Mental Health

Study Summary:

The above-referenced research protocol proposes to study the effects of a single 10 mg dose of dextroamphetamine in conjunction with functional magnetic resonance imaging in healthy children and children with attention deficit hyperactivity disorder (ADHD), all between 9 and 18 years of age. The overall goal of the proposed study is to better understand the pathophysiology of ADHD. The specific aims of the study are to: (i) study brain activation patterns during response inhibition tasks in children with ADHD and in healthy controls; (ii) simultaneously examine the central and behavior effects of a single-dose of amphetamine versus placebo in the two groups; and (iii) examine (using monozygotic and dizygotic twins) brain activation patterns in relation to clinical state and the degree of genetic relatedness.

Funding Source:

National Institute of Mental Health, National Institutes of Health

• NIH letter to OHRP requesting HHS 45 CFR 46.407 review of Protocol
• NIH withdraws request for HHS 45 CFR 46.407 review [RTF - 14.5KB]