Efficacy and Safety of Ritalin® LA™, a New, Once Daily, Extended-Release Dosage Form of Methylphenidate, in Children with Attention Deficit Hyperactivity Disorder

Joseph Biederman, Declan Quinn, Margaret Weiss, Sabri Markabi, Meredith Weidenman, Kathryn Edson, Goeril Karlsson, Harald Pohlmann, Sharon Wigal

Research output: Contribution to journalArticlepeer-review

93 Scopus citations

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.

Original languageEnglish
Pages (from-to)833-841
Number of pages9
JournalPaediatric Drugs
Volume5
Issue number12
DOIs
StatePublished - 2003
Externally publishedYes

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