title: 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.
authors: Department of Child and Adolescent Psychiatry, University Hospital Freiburg, Germany. eberhard.schulz@uniklinik-freiburg.de
authors: Eberhard
authors: E
authors: Schulz
authors: Christian
authors: C
authors: Fleischhaker
authors: Klaus
authors: K
authors: Hennighausen
authors: Philip
authors: P
authors: Heiser
authors: Frank
authors: F
authors: Haessler
authors: Martin
authors: M
authors: Linder
authors: Kirsten
authors: K
authors: Stollhoff
authors: Andreas
authors: A
authors: Warnke
authors: Monika
authors: M
authors: Baier
authors: Jan
authors: J
authors: Klatt
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005508:Food Deprivation; D018565:Food-Drug Interactions; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate