Can routine N-of-1 studies improve net benefits and reduce costs by better targeting chronic therapy?

This single patient (n of 1) trial is a randomised, double-blind, cross-over comparison of methylphenidate and placebo within an individual patient. The patient will undergo three pairs of treatment periods. The order of treatment in each cycle will be determined by random allocation. The choice of initial therapy will be balanced in blocks of four, to ensure that equivalent numbers start the IMET on each of the two medications. Patients, parents and practitioners will all be blinded to which treatment the patients are taking. Product information will be provided to the patient and parent at the beginning of the study. Parents, teachers, and patients over 12 years will complete ADHD Rating Scales at the end of two days (or one week for the 6 week IMET). If at any time during the study the patient feels worse, that treatment period can be terminated, and they can go on to the next treatment period. Upon completion of the study, the timing of the active treatment will be revealed. After looking at the symptoms recorded, the doctor and patient decide together whether methylphenidate is of significant benefit. If the patient chooses, they can then continue on that medication, confident that it is effective for them.