OBJECTIVE: To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This double-blind, randomized, placebo-controlled, crossover laboratory school study enrolled 78 children aged 9-12 years with ADHD who responded to OROS MPH. After determining individualized OROS MPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROS MPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week. Primary efficacy was measured by Permanent Product Measure of Performance at 4 hours after study drug administration. RESULTS: Treatment with OROS MPH resulted in statistically significant improvement in Permanent Product Measure of Performance and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores, measures of response time, and of working memory compared to placebo. Other measures did not meet all pre-established criteria for significance (maintenance of the overall type I error rate at 5%). Adverse events were consistent with previous reports of stimulant medications used in the management of ADHD. There were no discontinuations due to adverse events, and no serious adverse events or deaths. CONCLUSIONS:OROS MPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo. Adverse effects reported were consistent with prior studies. CLINICAL TRIAL REGISTRY INFORMATION: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of Concerta on Older Children with ADHD, URL: http://clinicaltrials.gov/ct2/show/NCT00799409, unique identifier: NCT00799409.
RCT Entities:
OBJECTIVE: To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This double-blind, randomized, placebo-controlled, crossover laboratory school study enrolled 78 children aged 9-12 years with ADHD who responded to OROSMPH. After determining individualized OROSMPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROSMPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week. Primary efficacy was measured by Permanent Product Measure of Performance at 4 hours after study drug administration. RESULTS: Treatment with OROSMPH resulted in statistically significant improvement in Permanent Product Measure of Performance and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores, measures of response time, and of working memory compared to placebo. Other measures did not meet all pre-established criteria for significance (maintenance of the overall type I error rate at 5%). Adverse events were consistent with previous reports of stimulant medications used in the management of ADHD. There were no discontinuations due to adverse events, and no serious adverse events or deaths. CONCLUSIONS:OROSMPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo. Adverse effects reported were consistent with prior studies. CLINICAL TRIAL REGISTRY INFORMATION: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of Concerta on Older Children with ADHD, URL: http://clinicaltrials.gov/ct2/show/NCT00799409, unique identifier: NCT00799409.
Authors: James J McGough; Sharon B Wigal; Howard Abikoff; John M Turnbow; Kelly Posner; Eliot Moon Journal: J Atten Disord Date: 2006-02 Impact factor: 3.256
Authors: William J Barbaresi; Slavica K Katusic; Robert C Colligan; Amy L Weaver; Cynthia L Leibson; Steven J Jacobsen Journal: J Dev Behav Pediatr Date: 2006-02 Impact factor: 2.225
Authors: F Xavier Castellanos; Edmund J S Sonuga-Barke; Michael P Milham; Rosemary Tannock Journal: Trends Cogn Sci Date: 2006-02-07 Impact factor: 20.229
Authors: Jennifer C Swart; Monja I Froböse; Jennifer L Cook; Dirk Em Geurts; Michael J Frank; Roshan Cools; Hanneke Em den Ouden Journal: Elife Date: 2017-05-15 Impact factor: 8.140
Authors: Brian Daly; Mary C Kral; Ronald T Brown; David Elkin; Avi Madan-Swain; Monica Mitchell; Lori Crosby; David Dematteo; Angela Larosa; Sherron Jackson Journal: J Dev Behav Pediatr Date: 2012-04 Impact factor: 2.225
Authors: Sharon B Wigal; Laurence L Greenhill; Earl Nordbrock; Daniel F Connor; Scott H Kollins; Akwete Adjei; Ann Childress; Annamarie Stehli; Robert J Kupper Journal: J Child Adolesc Psychopharmacol Date: 2014-12 Impact factor: 2.576
Authors: Sarah A Orban; Tanya A Karamchandani; Leanne Tamm; Craig A Sidol; James Peugh; Tanya E Froehlich; William B Brinkman; Nicole Estell; Akemi E Mii; Jeffery N Epstein Journal: J Child Adolesc Psychopharmacol Date: 2018-08-27 Impact factor: 2.576
Authors: Marieke E van der Schaaf; Sean J Fallon; Niels Ter Huurne; Jan Buitelaar; Roshan Cools Journal: Neuropsychopharmacology Date: 2013-04-23 Impact factor: 7.853
Authors: Ole Jakob Storebø; Erica Ramstad; Helle B Krogh; Trine Danvad Nilausen; Maria Skoog; Mathilde Holmskov; Susanne Rosendal; Camilla Groth; Frederik L Magnusson; Carlos R Moreira-Maia; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Bente Forsbøl; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2015-11-25