Release Date: January 21, 1998 This content is archived.
BUFFALO, N.Y. -- A University at Buffalo psychologist is conducting clinical trials of two long-acting drugs for attention deficit-hyperactivity disorder (ADHD) as part of the Federal Drug Administration approval process.
William E. Pelham, Ph.D., one of the leading researchers in ADHD in the U.S., has received $1.5 million from ALZA Corp. to carry out the first trial with children of a 12-hour formulation of methylphenidate, the active ingredient in Ritalin, the drug most commonly prescribed for ADHD.
He also is principal investigator on a $250,000 trial funded by Bristol-Myers Squibb of a potential new medication for ADHD delivered via a 24-hour skin patch. The drug -- Buspar -- currently is used to treat anxiety in adults. Buffalo is one of 40 sites involved in testing its use in children.
There currently is no effective long-acting medication for treating ADHD. Ritalin must be taken three times a day to achieve the necessary effect, a regimen that is particularly difficult for school-age children.
"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."
Participants in both trials must be between the ages of 6 and 12.
For the methylphenidate trial, children must be receiving Ritalin currently and responding well to it. The trial will be conducted at UB on five consecutive Saturdays. Participants will spend from 7 a.m. to 8:30 p.m. on campus, participating in meals, recreation and classroom activities. They will be assigned randomly to a drug regimen that will vary each week. Trained observers will record their behavior. In addition, parents and the children's teachers will receive free training in behavior management.
Children accepted into the methylphenidate trial will receive a complete diagnostic assessment, free medication and $25 every time they come for the study. Parents also will be paid for their time. This trial also needs children without ADHD to serve as a comparison group.
Children eligible to participate in the Buspar trial must not be taking any ADHD medication. They will be assigned randomly to receive either the new medication or a placebo for six weeks, and will be evaluated during that period by their regular classroom teachers. A complete free diagnostic workup will be performed prior to the trial startup.
• 716-645-3650, ext. 373, for the Buspar trial
• 716-645-3650, ext. 373, for the comparison group in the methylphenidate trial.