Quality of life of children with ADHD – prospective, multicenter non-interventional LECO-trial evaluating the impact on QOL, effectiveness and tolerability of OROS®-methylphenidate

Objectives: To investigate the effectiveness, tolerability and impact of OROS®-MPH on quality of life (QoL) of patients with ADHD who had been pretreated with IR-MPH under naturalistic conditions. Methods: Patients with ADHD (ICD-10), aged 6–18 years, were treated with OROS®-MPH once daily in flexible doses (18, 36 or 54mg/day) for 3 months (interim analysis 42603-ATT-4001). Assessments included Parent IOWA Conners rating scale, C-GAS, CGI, inventory for the assessment of QoL (ILK) and documentation of AEs. Results: Analysis of 296 patients (ITT (LOCF); mean age 10.4±2.5 years; 85% male) with 85% completing the full observation. Clinical symptoms improved from 29±11 to 19±11 points on the parent IOWA Conners rating scale (p<0.0001). Functionality showed an improvement of 12±14 points in C-GAS (p<0.0001). QoL significantly improved from 29±6 to 25±6 points for the parents (ILK Parent Rating Scale; p<0.0001) and from 21±5 to 18±5 points for the children (ILK Child Rating Scale; p<0.0001) when comparing baseline to endpoint. 19% (n=57) of patients had at least one AE rated as at least possibly related to OROS®-MPH by the treating physician. Most frequent AE was insomnia (5.7%). For over 85% of patients tolerability was rated as “good“ or “very good“. Conclusion: This non-interventional trial shows that OROS®-MPH in children and adolescents with ADHD is well-tolerated and effective. Findings support the positive impact of OROS®-MPH treatment on several aspects of QoL.

This study was supported by Janssen-Cilag GmbH, Neuss