Efficacy and Duration of Effect of Extended-Release Dexmethylphenidate Versus Placebo in Schoolchildren With Attention-Deficit/Hyperactivity Disorder
- 1 June 2006
- journal article
- research article
- Published by Mary Ann Liebert Inc in Journal of Child and Adolescent Psychopharmacology
- Vol. 16 (3), 239-251
- https://doi.org/10.1089/cap.2006.16.239
Abstract
The aim of this study was to assess changes in symptomatology of attention-deficit/ hyperactivity disorder (ADHD) with extended-release dexmethylphenidate (d-MPHER) versus placebo in a laboratory classroom setting. This double-blind, placebo-controlled, crossover study randomized 54 children 6-12 years of age, stabilized on methylphenidate 20-40 mg/day. Patients participated in a practice day, then received 5 days of treatment with d-MPH-ER 20 mg/day or placebo. After a 1-day wash-out, they returned to the classroom and received 1 dose of their assigned treatment. Evaluations occurred predose and at postdose hours 1, 2, 4, 6, 8, 9, 10, 11, and 12. Children were then crossed over to the alternate treatment, using identical protocol. Primary efficacy variable was the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP)-Combined scores, and primary analysis time point was 1 hour postdose; secondary efficacy variables over 12 hours included SKAMP-Attention and -Deportment scores and written math test results. Safety was assessed by adverse event (AE) recording following each period. Vital signs were recorded at each visit; laboratory tests were conducted at screening and final visit. D-MPH-ER 20 mg/day showed a significant advantage over placebo as early as 1 hour postdose on SKAMP-Combined scores (p < 0.001). When analyzing the entire sample of 54 children, d-MPH-ER maintained significant superiority over placebo from hours 1 through 12 (p-values ranged from < 0.001 to 0.046). D-MPH-ER was well tolerated, with no severe AEs reported. D-MPH-ER is safe and effective and improves classroom attention, deportment, and performance in children with ADHD.Keywords
This publication has 24 references indexed in Scilit:
- Open-Label Study of Dexmethylphenidate Hydrochloride in Children and Adolescents with Attention Deficit Hyperactivity DisorderJournal of Child and Adolescent Psychopharmacology, 2004
- Attention-Deficit/Hyperactivity Disorder in AdultsJAMA, 2004
- Genetics of adult attention-deficit/hyperactivity disorderPsychiatric Clinics of North America, 2004
- Brain function and structure in adults with attention-deficit/hyperactivity disorderPsychiatric Clinics of North America, 2004
- Executive dysfunction in attention-deficit/hyperactivity disorder: cognitive and neuroimaging findingsPsychiatric Clinics of North America, 2004
- A Comparison of Once-Daily Extended-Release Methylphenidate Formulations in Children With Attention-Deficit/Hyperactivity Disorder in the Laboratory School (The Comacs Study)PEDIATRICS, 2004
- Diagnosis and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and AdolescentsJAMA, 1998
- A Prospective 4-Year Follow-up Study of Attention-Deficit Hyperactivity and Related DisordersArchives of General Psychiatry, 1996
- The Efficacy of Stimulant Drug Treatment for HyperactivityJournal of Learning Disabilities, 1982
- A REVIEW OF STIMULANT DRUG RESEARCH WITH HYPERACTIVE CHILDRENJournal of Child Psychology and Psychiatry, 1977