Methylphenidate protocol: feasibility in a pediatric practice
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Double-blind trials of methylphenidate for attention deficit disorder (ADD) in pediatric practices are feasible. While many children did not benefit, the study design aids in assessing medication response.
Area of Science:
- Pediatric Practice
- Clinical Trial Design
- Pharmacological Treatment
Background:
- Attention deficit disorder (ADD) is a common diagnosis in children.
- Assessing medication efficacy in general pediatric settings presents challenges.
- Methylphenidate is a commonly prescribed medication for ADD.
Purpose of the Study:
- To evaluate the feasibility of conducting double-blind, placebo-controlled methylphenidate trials in a general pediatric practice.
- To assess the therapeutic benefit of methylphenidate in children diagnosed with attention deficit disorder.
- To determine the suitability of this trial methodology for private pediatric practices.
Main Methods:
- A three-week protocol involving baseline, methylphenidate, and placebo weeks.
- Utilized Connors rating scales completed by parents and teachers for assessment.
- Employed a double-blind, randomized crossover design with medication/placebo order unknown to participants and investigator.
Main Results:
- Initial pilot phase showed a 53% trial completion rate, improved to 83% with modifications.
- 43% of children identified as hyperactive did not show benefit from methylphenidate.
- Discrepancies in parent and teacher ratings occurred in six trials.
Conclusions:
- Double-blind trials for methylphenidate in attention deficit disorder are feasible in general pediatric practices.
- The methodology, despite some challenges, aids in assessing individual medication response.
- The study design is adaptable for evaluating ADHD treatments in community-based pediatric settings.
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.