To explore the relationship between symptomatic and functional outcomes in a five week, double blind, fixed dose, placebo controlled study in adults (age 18-65 years) with ADHD.

Post hoc-analysis of a five-week, double-blind (DB), parallel arm, placebo-controlled trial in adult subjects with ADHD (DSM-IV) and a Conners’ Adult ADHD Rating Scale (CAARS) score >= 24 at baseline. Subjects were randomized to OROS-MPH (18mg, 36mg, 72 mg/day) or placebo. Symptomatic outcomes were assessed by total CAARS score (TCS). Functional outcomes were assessed by Sheehan Disability Scale (SDS) total score and subscales (work, social life and family life), quality of life by Q-LES-Q total score. The relationship of CAARS with SDS and Q-LES-Q was assessed by Pearson's partial correlation analysis, with adjustment for baseline scores of CAARS, SDS, Q-LES-Q, CGI-S, age, sex, and randomization group.

401 subjects were enrolled (54.4% male, mean (SD) age 34 (10.24) yrs). There was a significant treatment effect as measured in TCS at DB endpoint for all OROS MPH treatment groups compared to placebo (P< 0.05). The absolute value of partial correlations of symptomatic outcome with functional outcomes and quality of life varied between 0.54 and 0.36; all correlations were significant (p< 0.0001). These correlations were compared between the functional and quality of life measures, but none differed significantly.

Subjects’ symptomatic improvements during treatment with PR OROS MPH are reflected in improvements in their vocational and social function as measured by the SDS, and quality of life.