Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
Completed
University of Nebraska
Phase 4
2008-10-01
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in
treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children.
Virtually no data has been published on the use of long-acting stimulant preparations in very
young children despite early symptomatic development in a significant portion of young
children with ADHD. This would be one of the first studies looking at a long-acting
preparation of a stimulant medication in the treatment of ADHD in very young children.
Hypotheses
1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old
children.
The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH
(methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the
N-1-T design both for individual clinical decision making and for clinical trials in symptom
management in pediatric oncology patients. Because no one knows which of the study options
are best, participants will receive liquid MPH on some days and a placebo on other days. We
will compare how the participant feels on MPH days with how they feel on placebo days to
determine whether MPH makes a difference.
The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH
(methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the
N-1-T design both for individual clinical decision making and for clinical trials in symptom
management in pediatric oncology patients. Because no one knows which of the study options
are best, participants will receive liquid MPH on some days and a placebo on other days. We
will compare how the participant feels on MPH days with how they feel on placebo days to
determine whether MPH makes a difference.
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