Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: A 13-week, randomized, double-blind, placebo-controlled, fixed-dose study

Abstract

Objectives. Methylphenidate (MPH) is effective for adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to evaluate the efficacy and safety of OROS MPH in adults with ADHD. Methods. Randomized, double-blind study; 279 subjects received OROS MPH 54 or 72 mg/day, or placebo, for 13 weeks. Primary endpoint was the Conners’ Adult ADHD Rating Scale – Screening Version (CAARS-O:SV). Secondary outcomes included CAARS Self Report – Short Version (CAARS-S:S), Sheehan Disability Scale (SDS) and ADHD Impact Module – Adult (AIM-A). Results. Improvements in CAARS-O:SV were significantly greater with OROS MPH 72 mg vs. placebo (P = 0.0024). CAARS-S:S scores decreased significantly vs. placebo in both OROS MPH arms (P < 0.05). There was no significant change in SDS score from baseline in either treatment arm, although significant benefit vs. placebo was observed on several AIM-A subscales. Treatment was well tolerated. Conclusions. OROS MPH provided overall benefits in the treatment of adults with ADHD.