To explore the relationship between symptomatic and functional outcomes in adults (age 18-65 years) with ADHD during open label treatment with PR OROS MPH.

Post hoc analyses of a 7-week open-label extension (OLE) (N=370) of a 5 week, placebo controlled double-blind study (DB) which explored safety, efficacy, functional and quality of life outcomes in subjects with a diagnosis of ADHD (DSM-IV). Medication was flexibly dosed (18-90 mg/day) and adjusted individually to best effect during OLE. Regression analyses were performed on the change from DB baseline at OL endpoint in functionality and quality of life as measured by the Sheehan Disability Scale (SDS) and Quality of Life (Q-LES-Q). Baseline score, country, randomization group, sex, change from baseline in CAARS Hyperactivity / Impulsivity, CAARS Inattention and CGI-S at DB endpoint were included as covariates in the analyses.

337 / 370 patients completed the 7-week open label treatment. Improvement on CAARS Hyperactivity / Impulsivity at DB endpoint was significantly related with improvement in SDS “work”, “social life”, “family life” (at least p< 0.005) and “total score” as well as quality of life (p< 0.05) at the end of open label treatment. Change in CGI-S and CAARS Inattention at DB endpoint vs. DB baseline were not related with improvements in any of the functional or quality of life scales at OL endpoint (p>0.05).

These results indicate that improvement in daily functioning and QOL under active treatment may be particularly related to improvement in hyperactivity symptoms.