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 UB researchers has shown.
The extended-release formulation of methylphenidate avoids the need for children to take medication during school or after-school activities.
The trial of Concerta was headed by William E. Pelham, 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 methylphenidate that will last from early morning into the early evening.
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.
Results showed that children performed significantly better on both the three-times-a-day and the extended-release medications in all settings than when receiving the placebo. The extended-release formulation maintained its effectiveness even after 12 hours in both the laboratory and home settings, findings indicated. Ratings were similar for both active formulations.