A randomized, rater-blinded, crossover study comparing the clinical efficacy of Ritalin® LA (methylphenidate) treatment in children with attention-deficit hyperactivity disorder under different breakfast conditions over 2 weeks

Abstract

Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDS(Teacher): 0.97 with minimal breakfast, 1.01 with standard breakfast, P < 0.0001). The clinical efficacy of Ritalin LA is not influenced by breakfast and works independently of food intake.

Methylphenidate and dexmethylphenidate formulations for children with attention-deficit/hyperactivity disorder

“…The morning dose can be taken with or without breakfast and still maintain the same first peak concentration and extent of absorption. 23 Ritalin LA ® capsules have also been compared to Concerta ® in a single-blind, placebo-controlled, crossover study. 24 In the study, Ritalin LA 28 Transdermal delivery of methylphenidate provides a treatment option for children who have difficulty swallowing oral medications or if they would benefit from tailoring the duration of effect specifically for their daily needs.…”

Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials

“…8 , 9 A racemic D,L-methylphenidate hydrochloride has been proved to be effective and has been widely prescribed for ADHD. 10 – 12 Dexmethylphenidate (d-MPH) hydrochloride is a D-threo enantiomer of racemic D,L-methylphenidate with an approximately tenfold greater potent pharmacological effect than L-methylphenidate. 13 After oral administration, d-MPH does not racemize; therefore, it is possible for it to reach similar efficacy at approximately half the dose of racemic D,L-methylphenidate.…”