Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found
that daily stimulant therapy produced sustained growth deficits. However, no federally funded
studies have examined the growth suppression associated with modern once a day stimulant
medications. Therefore, this study will precisely estimate the risks of stimulant induced
growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it.
While drug holidays and caloric supplementation are two common treatments for SIGS, there has
been little systematic investigation of either. It is unknown if they are effective or
feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and
feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal
children with ADHD. An additional 50 subjects will be treated solely with behavioral
therapies to evaluate for growth abnormalities associated with ADHD. The study will assess
will the risk of SIGS with ER stimulants and the underlying mechanisms while providing
evidenced-based treatments for its management.