Release Date: June 4, 2001
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.
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.
Parents, teachers and children in the study also took part in a concurrent regimen of behavior modification. Combining behavioral modification with medication is the best way to treat ADHD, Pelham noted.
Assessing the clinical trial itself, Pelham said: "Because it is given only once per day, Concerta should improve compliance with ADHD children's medication regimens and afford smoother treatment effects throughout the day."
Pelham acknowledged that some ADHD children do not need medication in the evening, and that some parents prefer not to use medication for their ADHD children. "For those who do, however, Concerta would appear to be a good choice of stimulant medications as part of a total treatment package for ADHD," he said.
Also participating in the trial were Martin T. Hoffman, M.D., and Thomas M. Lock, M.D., of the Department of Pediatrics, UB School of Medicine and Biomedical Sciences; Gene D. Morse, Pharm.D., and Karl Fiebelkorn, R.Ph., of the Department of Pharmacy Practice, UB School of Pharmacy and Pharmaceutical Sciences; Lisa Burrows-Maclean, Ph.D., and Elizabeth Gnagy of the Center for Children and Families in UB's College of Arts and Sciences.
UB psychology graduate students Andy Williams, Gregory A. Fabiano, Sean M. Morrisey, Andrea M. Chronic, Gregory L. Forehand, Celeste A. Aguyenm, Erika K. Coles, Carlos J. Panahon, Randi L. Steiner, David L. Meichenbaum and Adia N. Onyango also took part.
The trial was sponsored by a grant from Alza Corp., manufacturer of Concerta. Pelham's research is supported by grants from the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health.