BUFFALO, N.Y. -- A new 12-hour formulation of the most commonly prescribed drug for attention-deficit/hyperactivity disorder, or ADHD, has proved to be as effective as the standard three-times-a-day dosing regimen, a clinical trial conducted by University at Buffalo researchers has shown.
The extended-release formulation of methyphenidate avoids the need for children to take medication during school or after-school activities.
The trial of Concerta was headed by William E. Pelham, Ph.D., professor of psychology, pediatrics, and psychiatry at UB and one of the world's leading authorities on attention deficit disorder. Results appear in the electronic pages of the June issue of Pediatrics.
Researchers have been working for some time to develop an effective and safe extended-release form of methyphenidate that will last from early morning into the early evening.
"Kids have a terrible problem taking pills at school," Pelham said. "There are few school nurses anymore, which means the children have to receive their medicine from the teacher or from someone in the school office. Kids have to remember to do that. The problems get worse as they get older, because teens don't want their friends to see them taking medication."
The trial was conducted with 68 children between the ages of 6 and 12 who already were taking a version of methylphenidate for ADHD. The double-blind design involved three dosing regimens: immediate-release methylphenidate given three times a day; extended-release methylphenidate given in the morning, and placebo. All children took each regimen for a week.
Teachers and parents rated the children's behavior and ability to attain daily goals during the week. In addition, children spent 12 hours on Saturdays in a classroom laboratory setting to allow researchers to evaluate the effects of each medication over time. Trained investigators monitored behavior during classroom work, games and recess.