Observations on effects of a central stimulant drug (methylphenidate) in children with hyperactive behavior.

Ninety-eight hyperactive children, ages 6 to 12 years, have been treated with methylphenidate or placebo under double-blind conditions. Only one of the 48 children receiving placebo (2%) was judged to be a drug success. Seventy-nine percent of the 94 children receiving methylphenidate were judged to be drug success at the end of the 16-week trial period. A wide range of dosage (0.2 to 1.9 mg/kg) was required for optimum drug effects. Drug failures were due either to appearance of withdrawn, apathetic behavior in the child (6 cases) or lack of evidence of drug effectiveness (14 cases). Overweight children did not respond well to medication even though milligram per kilogram dosage was equivalent to that in children who were categorized as drug successes. The most dramatic successes were seen in children who might be characterized as exhibiting "developmental hyperactivity," i.e., hyperactivity in the absence of other evidence of neurological or emotional disturbances. We conclude that a trial of stimulant drugs is clearly indicated in hyperactive children manifesting significant impairment of educational and social progress. Dosage adjustment and judgement of drug success or failure require regular reports from teachers and parents.

RCT Entities:   Population Interventions Outcomes