Methylphenidate Protocol: Feasibility in a Pediatric Practice

Abstract

This report examines the feasibility of double blind individual trials of methylphenidate versus placebo in a general pediatric practice to assess benefit of this medication in the treatment of attention deficit disorder. Children presenting with the diagnosis of attention deficit disorder were enrolled in a three-week protocol. The first week was a baseline week during which teachers and parents completed the Connors rating scales. During the second and third weeks of each trial, placebo or methylphenidate was given for a week each in an unknown order to parents, teachers or the investigator. Respective Connors rating scales were also completed for each of these weeks. At the end of the third week, the three parent questionnaires and the three teacher questionnaires were returned to the investigator for scoring and disclosure about findings. During a pilot period, 53% of the trials were improperly completed. Reasons for this were addressed and with simple measures the rate of successful completion was raised to 83%. During the study phase, 43% of the children were found to be hyperactive but they did not benefit from medication. In six trials there was disagreement between teachers and parents. The completed trials and many of the incompleted trials were helpful in the assessment of the children with attention deficit disorder and their response to medication. It is felt that this approach is suitable for a private general pediatric practice.