Advantages of Starting Methylphenidate in a Double-Blind Trial

Background/Purpose: There is a wide spread use of methylphenidate with numbers still increasing. On the same time, there is a growing distrust against the use of the drug, sharp discussion about the use of methylphenidate. For example, it is always the case that children do not receive the drug, which could benefit significantly from the therapy. It needs an ideology-free access to the trust of the parents.

Methods: Methylphenidate and placebo are administered in increasing dosages for 3 weeks each. The parents receive two envelopes, labeled “A” and “B,” one with placebo, one with verum and free choice, with which envelope they start. We in the SPZ know what the contents of the envelopes, but not with which envelope the family starts. The parents also receive a sealed envelope with which they can end the blinded trial at any time. For both phases, the observations are compared in evaluation session and are compared with parents' assessments (FBB-ADHS) by parents, teachers and possibly also caregivers, integration assistants and therapists.

Results: Our experience is that with the double blinded trial we are given greater certainty as to whether the drug has a benefit beyond the placebo effect. Through the double blinded design, the children are observed more closely and the observations are more differentiated. For us, the advantages in everyday life are so convincing that we use this way of testing methylphenidate in both SPZs in Mülheim and Oberhausen in more than 90% of cases.

Conclusion: We can recommend the method of the placebo controlled double blinded trial as an everyday, pragmatic and effective routine. The effort is greater initially, but this pays off for more trust of the parents and for more objective information.