A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan

• Published in: The world journal of biological psychiatry 2014-08, Vol.15 (6), p.488-498
• Main Authors: Takahashi, Nagahide, Koh, Tadaishi, Tominaga, Yushin, Saito, Yuki, Kashimoto, Yuji, Matsumura, Taka
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adolescent; Adult; attention deficit disorder with hyperactivity; Attention Deficit Disorder with Hyperactivity - drug therapy; Central Nervous System Stimulants - administration & dosage; Central Nervous System Stimulants - adverse effects; Central Nervous System Stimulants - pharmacology; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Japan; Male; methylphenidate; Methylphenidate - administration & dosage; Methylphenidate - adverse effects; Methylphenidate - pharmacology; Middle Aged; Placebos; randomized controlled trial; Treatment Outcome; Young Adult
• ISSN: 1562-2975; 1814-1412
• DOI: 10.3109/15622975.2013.868925

Abstract Objectives. To evaluate the safety and efficacy of osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) HCl in adults with attention-deficit/hyperactivity disorder (ADHD). Methods. In this study, 284 adults with ADHD were randomized to OROS MPH or placebo. During the 4-week titration period, patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments. Patients continued on their individualized dose during the 4-week efficacy assessment period. The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O:SV) from baseline to endpoint. Results. The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O:SV was significantly larger with OROS MPH compared with placebo (P < 0.0001, ANCOVA). Similar results were observed for the majority of secondary endpoints, including CAARS-O:SV total score and other subscale scores. Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81.8%) versus the placebo group (53.9%), OROS-MPH showed a well-tolerated safety profile overall. Conclusions. OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD.