SAN FRANCISCO – Extended-release methylphenidate is effective in reducing the symptoms of attention-deficit hyperactivity disorder in adolescents, Linda Pfiffner, Ph.D., said at a meeting on clinical pediatrics sponsored by the University of California, San Francisco.
The study is significant because few placebo-controlled studies of medication for ADHD in adolescents have been conducted, said Dr. Pfiffner of the university. The randomized, double-blind, placebo-controlled study involved 177 boys and girls, aged 13–18 years, with a confirmed diagnosis of ADHD. During a 4-week, open-label period, the children were titrated to a dose of methylphenidate (Concerta) that resulted in at least a 30% improvement in ADHD symptoms, as rated by the investigators.
They were then randomized to receive placebo or their individualized methylphenidate dose for 2 weeks, after which they were eligible to participate in an 8-week open-label follow-up.
During the titration phase, 36.7% of the children reached a daily dose of 72 mg, the highest dose offered. Smaller proportions of children settled at lower doses: 27.7% at 54 mg, 28.2% at 36 mg, and 7.4% at 18 mg.
At the end of the titration phase, the mean investigator rating of ADHD symptoms fell 86% from baseline.
At the end of the double-blind phase, investigators, parents, and the children themselves independently recorded significant improvements in ADHD symptoms in favor of methylphenidate.
In fact, the patient self-assessments showed a larger difference between the placebo and active medication groups than the investigators or the parents. This suggests that the children may be more sensitive in their judgments of efficacy than the outside observers, Dr. Pfiffner said.
The study was supported by McNeil Consumer & Specialty Pharmaceuticals, which manufactures Concerta.