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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.
Acknowledgements
We would like to acknowledge all patients, physicians and research coordinators who participated in this clinical trial.
Statement of Interest
NT, TK, YT, YS, YK and TM are employees of Janssen Pharmaceutical KK, Japan.
This study was supported by Janssen Pharmaceutical KK, Japan. Editorial support was provided by Allison Michaelis, PhD, of Medergy and was funded by Janssen Global Services, LLC.