The purpose of this study is to see if supplementing calories with Pediasure is effective in
maintaining height, weight, and BMI percentiles for young children during 2 years of
treatment with ADHD medication.
This is a pilot study evaluating the effect of caloric supplementation on maintenance of
growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old
children with ADHD. The study will assess the efficacy of caloric supplementation in
maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients
will be randomly assigned to receive either PediaSure for caloric supplementation, or no
Secondary aims include assessing the tolerability and efficacy of long-term, open-label
atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot
data regarding the safety, efficacy, and potential effects of atomoxetine on growth
parameters in order to submit a multisite R01 to more adequately assess atomoxetine
treatment and its effects in young children with ADHD.
- Children who participated in the 8 week DBPC trial of atomoxetine (1K23MH066127) who
wish to participate in a long-term, open label trial of atomoxetine.
- Parents and patients must be able to attend regular study visits. Visits will be
scheduled every 30 days for the first 6 months and then every 60 days for the next 18
- Children who are on alternate medications due to inefficacy or intolerability of
atomoxetine may still participate.
- Parents who are unwilling to provide informed consent.