DOUBLE-BLIND VERSUS OPEN EVALUATIONS OF STIMULANT DRUG RESPONSE IN CHILDREN WITH ATTENTION-DEFICIT HYPERACTIVITY DISORDER

Although placebo controls and double-blind conditions are considered t o be essential for the unbiased scientific assessment of drug effects, there is very little research on these procedures in the pediatric ps ychopharmacology literature. To examine the impact of controlled asses sment procedures on the magnitude of observed drug effects, two groups of children with attention-deficit hyperactivity disorder (ADHD) were evaluated for response to methylphenidate under two different assessm ent procedures. One group (n = 33) was part of a placebo-controlled, d ouble-blind crossover research protocol, with randomized dose sequence s, compliance checks, numerous dependent measures, written informed co nsent, and a considerable amount of staff involvement. The other group (n = 43) received pharmacotherapy at a community-based child psychiat ry outpatient service where they were followed in a routine clinical m anner, with ''no treatment'' as the only control condition, standard f ixed-dose titration, parental responsibility for data collection, use of form letters, and minimal staff involvement. Each individual in bot h groups received divided doses of 0.3 and 0.5/0.6 mg/kg daily for a m inimum of 1 week at each dose. Comparisons of teacher ratings obtained for the two assessment procedures revealed highly similar findings. T he results of this study are discussed with regard to both their metho dological and clinical implications.