Track topics on Twitter Track topics that are important to you
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo.
The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral and cognitive effects of CONCERTA® (methylphenidate HCl) on older children with ADHD This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2 laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of methylphenidate HCl. The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
methylphenidate HCl, methylphenidate HCl
Ortho-McNeil Janssen Scientific Affairs, LLC
Published on BioPortfolio: 2014-07-24T14:15:07-0400
Methylphenidate (MPH) is the first-line pharmacological treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD). Nevertheless, there is considerable interindividual varia...
The purpose of this study is to evaluate the efficacy and safety of OROS® Methylphenidate HCl as compared with placebo and standard immediate-release Ritalin® (taken three time per day) ...
The purpose of this pilot study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (methylphenidate hydrochloride extended-release tablets), a central nervou...
The purpose of the study is to investigate the clinical benefit of switching children with ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the correct do...
The purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyp...
To assess the Empathizing Quotient (EQ) of patients diagnosed with attention-deficit/hyperactivity disorder (ADHD) only or comorbid with oppositional defiant disorder (ODD) and compare the two groups'...
Although numerous studies report positive effects of methylphenidate on academic performance, the mechanism behind these improvements remains unclear. This study investigates the effects of methylphen...
This phase 3, laboratory classroom study assessed the efficacy and safety of methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) compared with placebo in children with attention...
To compare children with attention-deficit/hyperactivity disorder (ADHD), before and after the use of methylphenidate, and a control group, using tests of working memory, inhibition capacity and menta...
Emotional dysregulation (ED) is a frequent feature of attention-deficit/hyperactivity disorder (ADHD). It can be observed as a dysregulation profile or a deficient emotional self-regulation (DESR) pro...
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-IV)
A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...