Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder

Abstract

Objective: To evaluate the safety and efficacy of extended-release methylphenidate with a bimodal profile using SODAS technology (Ritalin LA ) compared with placebo in children aged 6-14 years with attention deficit hyperactivity disorder (ADHD).

Method: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. Following titration and a 1-week placebo washout period, patients were randomized to 2 weeks of double-blind treatment with either Ritalin LA (10-40 mg/day) or placebo. The efficacy assessments used were the Conners' ADHD/DSM-IV Scales for teachers (CADS-T) and for parents (CADS-P), and the Clinical Global Impression-Improvement Scale (CGI-I) completed by the investigator. The primary efficacy variable was the change from baseline (end of placebo washout) to the final rating (end of 2-week double-blind treatment) in the CADS-T Total subscale score.

Results: One-hundred-and-sixty-one children were treated and 134 responders were included in the intent-to-treat analysis. Ritalin LA achieved a mean change from baseline (+/- SD) on the CADS-T Total subscale of -10.7 (+/-15.68) compared with 2.8 (+/-10.59) for placebo (p < 0.0001); the effect size on the CADS-T Total score with Ritalin LA was 0.90. Additionally, 69.8% of patients in the Ritalin LA group were rated as much or very much improved on the CGI-I at final assessment compared with 40% of patients in the placebo group (p = 0.0009). The adverse events reported were generally mild or moderate, and were similar in both groups.

Conclusion: The results demonstrate that Ritalin LA administered once daily for up to 2 weeks achieved outcomes statistically superior to placebo in children with ADHD.