A double blind placebo controlled crossover study to determine the effects of atomoxetine on event-related potentials in response to auditory oddball stimuli during an on-the-road driving test in adult patients with attention deficit hyperactivity disorder

INTERVENTION: Trade Name: Strattera Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atomoxetine hydrochloride CAS Number: 82248597 Other descriptive name: Strattera Concentration unit: mg milligram(s) Concentration type: equal Concentration number: ‐60 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: The effects of atomoxetine on driving performance, attention and response inbihition are studied in adult patients with attention‐deficit hyperactivity disorder PRIMARY OUTCOME: Main Objective: To assess the effects of atomoxetine on driving ability and on attentional processes during driving in ADHD patients. Primary end point(s): Improved driving performance (a.o. weaving of the car) with atomoxetine compared to placebo. Improvement in attention during driving as reflected in event‐related potentials (ERPs) associated with inattention and attentional capacity with atomoxetine as opposed to placebo. Better inhibitory control with atomoxetine as measured with the stop‐signal‐task and related ERPs. Secondary Objective: Study the effect of atomoxetine on stop performance and ERPs related to inhibitory control INCLUSION CRITERIA: ‐Adult men and women diagnosed with ADHD ‐Possession of a valid driver's license for at least 3 years ‐For women of childbearing potential, a negative urine beta‐HCG pregnancy test result at test days ‐Normal static binocular acuity, corrected or uncorrected ‐Normal hearing ‐Be considered as reliable and mentally capable of adhering to the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range