Children with attention-deficit/hyperactivity disorder who wore Daytrana methylphenidate transdermal patches for stretches of 4 or 6 hours experienced improvements in their ADHD symptoms, results from a multicenter controlled trial of 117 young patients showed.
The findings “suggest that the duration of effect for ADHD is related to the length of time that the patch is worn, thereby offering flexibility in the duration of effect on ADHD up to the recommended 9-hour wear time,” Dr. Timothy E. Wilens and his associates reported.
A previous study showed improvements in ADHD symptoms from 2 to 12 hours with a 9-hour wear time; but prior to the current trial, the researchers explained, no data were “available on the duration of action of shorter wear times of the patch or the length of time after patch removal that symptoms of ADHD return appreciably.”
For the multicenter, placebo-controlled, randomized, double-blind, crossover study, 117 children with ADHD aged 6–12 years underwent optimal methylphenidate dosing over a 5-week period using 10-, 15-, 20-, or 30- mg patches worn for 9 hours. The efficacy of 4- and 6-hour wear times was then assessed in analog classroom sessions during weeks 6–8. Follow-ups were conducted at week 12 (J. Am. Acad. Child Adolesc. Psych. 2008;47:700–8).
The main efficacy measures were the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) deportment scale and the Permanent Product Measure of Performance (PERMP) math test. Secondary efficacy measures included the Attention-Deficit/Hyperactivity Scale IV, the Clinical Global Impressions-Improvement, the Parent Global Assessment, and the Conners' Parent Rating Scale.
Dr. Wilens of Harvard Medical School and the pediatric pharmacology unit at Massachusetts General Hospital, both in Boston, and his associates reported that all efficacy measures indicated that the 4- and 6-hour wear times improved ADHD symptoms, and that medication effects as measured by the SKAMP deportment scale and the PERMP math problems assessment decreased 2–4 hours after patch removal.
Adverse effects were mild or moderate and limited to those most commonly seen with traditional methylphenidate treatment: decreased appetite and headache.
The study was funded by Shire Development Inc., which manufactures the Daytrana patches. Dr. Wilens and his associates disclosed that they receive or have received research support from, acted as a consultant to, and/or served on the speakers bureaus of many pharmaceutical companies, including Shire.
The researchers said further studies are needed “evaluating the impact of variable wear times on specific short- and longer-term adverse effects.”