Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/
Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant
medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is
to evaluate if there are differences in sleep and other side effects, such as changes in mood
or loss of appetite, which can occur with stimulant medications. A third purpose is to
determine if there are differences in the characteristics of individuals who respond better
to either of the medications.
This research is being done because the investigators do not know if one of these two
commonly used treatments is better tolerated than the other. Children and adolescents with
ADHD often have a hard time sitting still, playing quietly, finishing things they start,
paying attention, waiting their turn, and not distracting others. These medications improve
these symptoms, but sometimes affect sleep, appetite, or mood.
It is hypothesized that at effective and frequently prescribed doses, Adderall will be
associated with insomnia, more stimulant side effects, and decreased tolerability during an
acute trial relative to Focalin.
Phase:
Phase 3
Details
Lead Sponsor:
Seattle Children's Hospital University of Illinois at Chicago