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Transdermal drug-delivery system found to be effective in ADHD treatment
By PATRICIA DONOVAN
Contributing Editor
Studies conducted at UB have demonstrated that a daily transdermal administration of methylphenidate (MPH, brand name Ritalin) is highly effective in treating children with Attention Deficit/Hyperactivity Disorder (ADHD).
In many cases, administration of the methylphenidate via transdermal patch (MTS) was found to be more effective than comparable oral doses, with the highest MTS or MPH doses producing the greatest effect and low-dose MTS plus behavior modification proving to be as effective as high-dose MPH alone.
The studies were conducted during a summer treatment program for ADHD children at UB and results were reported to the Pediatric Academic Society symposium, held on Saturday in Seattle.
The principle researcher was William E. Pelham, Jr., professor of psychology and psychiatry, director of the Center for Children and Families at UB and one of the nation's most distinguished researchers in the field. Martin Hoffman, associate professor of clinical pediatrics, and Lisa Burrows-Maclean, clinical assistant professor of pediatrics and psychology who is affiliated with the Center for Children and Families, also were involved in the study.
The researchers reported that overall, the children's behavior and performance improved whether the MPH was administered orally or through the patch. A wide range of transdermal doses proved effective, however including the lowest dose, which suggests that low-dose MTS may have a greater effect than comparable oral doses of the drug.
They also found that when low doses of the drug were administered transdermally along with behavioral modification, the effect on behavior and performance was the same as achieved with high dose of MPH alone.
The research team conducted two studies. In one study—a multi-center double-blind, randomized, dose-ranging, eight-day crossover study of 36 children ages 6-13 with ADHD—the children received different doses of MTS or placebo.
In a second, single-center, six-week, randomized, double-blind study, 27 children with ADHD ages 6-12 received varying daily doses of MTS or placebo Monday through Thursday for 8.5 hours. On three Fridays, participants received MTS at two different dose levels for six hours and completed timed math tests every two hours, beginning two hours after MTS administration and lasting four hours after the MTS was removed.
To determine outcome, behavioral points were measured during the day and teacher/counselor ratings and parents' reports of evening behavior were assessed.
Behavioral modification was given on four alternating weeks to all participants in the summer treatment program. During non-behavioral modification weeks, behavioral-modification components were removed and rewards given on an unpredictable schedule.
The eight-day study, found that:
All three active drug treatments (MTS, MTS plus behavioral modification, oral MPH) produced significant results, as compared to placebo, in the participants' ability to follow rules, comply with instructions and requests, and reduce instances of interruption and negative verbalization, with higher doses proving more effective.
Higher doses also resulted in a significant decline in complaining behavior.
Counselor/teacher ratings showed significant improvement with all three treatments, except for oppositional/defiant ratings at the lowest dose.
The six-week study found that:
All MTS doses on the Monday-through-Thursday regimen significantly improved day and evening ratings, compared with placebo.
The effect of low-dose MTS plus behavior modification was equivalent to high-dose MTS alone.
The highest MTS dose produced larger effects that remained stable during the day.
On Fridays, when two dose levels of MTS were administered, the higher dose improved behavior during the math task, but both high and low doses improved math-task performance overall.
All effects were stable until MTS was removed, and tapered off post-removal.