At a glance
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Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
In Brief
A Phase 3 clinical trial evaluating behavior therapy, Extended release (ER) methylphenidate product, and 3 other interventions for ADHD and Growth. Completed, enrolled 230 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
combination of individual and group parent training plus school consultation
medication to be taken daily for duration of study unless assigned to weight promotion arm
monthly weight, height and BMI checks
switch from seven day a week dosing to medication only on school days
continue current ADHD regimen and add one 8oz liquid caloric supplement at night