To investigate the effectiveness, tolerability, functionality and quality of life (QoL) under naturalistic conditions of once daily extended release methylphenidate (OROS®-MPH) in children and adolescents with attention-deficit/hyperactivity-disorder (ADHD), who had previously been treated with IR-MPH.

Interim analysis of an open-label, prospective, multicenter observational study (42603-ATT-4001) in children and adolescents aged 6-18 years with ADHD (DSM-VI). After transition patients were treated with OROS®-MPH (CONCERTA®) in flexible doses for 3 months. Primary documentation parameters were change in IOWA Conners' parent rating scale, C-GAS, and inventory for the assessment of quality of life (ILK). Statistical analyses based on ITT population (LOCF, Wilcoxon-test for dependent samples).

Data from 296 patients (mean age 10.4±2.5 years; 85% male) were documented. There was a marked reduction in symptomatology from 29±11 to 19±11 points at endpoint on the IOWA Connor's parents rating scale (p<0.0001). QoL significantly improved from 17±4 to 20±4 points on the ILK parent rating scale (p<0.0001). Functionality showed a significant improvement of 12±14 points in C-GAS (p<0.0001). 19.3% of the patients had at least one adverse event (AE). In 2 patients serious AE were documented and were rated as unrelated to OROS®-MPH. Most frequent AEs were insomnia (5.7%) and nervousness (2.7%). Tolerability after transition to OROS®-MPH was rated as "good" or "very good" by 85% of the parents.

In this naturalistic study the transition to OROS®-MPH led to a significant improvement in clinical symptomatology, functionality and quality of life in patients with ADHD. OROS®-MPH showed to be safe and well tolerated.