Lab School Study for CONCERTA

12:55 EDT 24th October 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Attention Deficit Hyperactivity Disorder

Intervention

methylphenidate HCl, methylphenidate HCl

Status

Completed

Source

Ortho-McNeil Janssen Scientific Affairs, LLC

Results (where available)

View Results

Links

Clinical Trials [715 Associated Clinical Trials listed on BioPortfolio]

A Multicenter Study Comparing the Efficacy and Safety of OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder

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) ...

CONCERTA® (OROS® Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults

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A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder

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Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)

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PubMed Articles [7705 Associated PubMed Articles listed on BioPortfolio]

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

Current literature on the safety and efficacy of various intermediate- and long-acting preparations of methylphenidate and dexmethylphenidate for pediatric attention-deficit/hyperactivity disorder (AD...

Methylphenidate and suicidal ideation: Report of two cases.

Stimulant prescriptions are routinely used to treat Attention Deficit Hyperactivity Disorder. Reports of psychiatric symptoms that have occurred include euphoria, delirium, confusion, toxic psychosis,...

Acute dose-related differential effects of methylphenidate on murine cystometric parameters.

Methylphenidate is the most widely used central nervous system stimulant in patients with attention deficit hyperactivity disorder. However, few studies have assessed its effects on voiding. Various d...

Methylphenidate use in dogs with attention deficit hyperactivity disorder (ADHD). A case report of a Weimaraner bitch.

A 10-month-old Weimaraner bitch was presented at the practice exhibiting agitation, hyperactivity, inability to learn and attention defi- cit. The diagnostic findings were excessive, long-lasting acou...

Methylphenidate-osmotic-controlled release oral delivery system treatment reduces parenting stress in parents of children and adolescents with attention-deficit/hyperactivity disorder.

The aim of the current study was to investigate the effect of methylphenidate-osmotic release oral delivery system (MPH-OROS) treatment on parenting stress in parents of children and adolescents with ...

Medical and Biotech [MESH] Definitions

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)

The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.

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