Track topics on Twitter Track topics that are important to you
The purpose of this pilot study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (methylphenidate hydrochloride extended-release tablets), a central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD).
CONCERTA® is a long-acting form of methylphenidate (a CNS stimulant). Methylphenidate is a recognized first-line treatment for ADHD in children and adolescents. It is widely acknowledged in the scientific literature that the disorder often will persist in adulthood, and is associated with significant morbidity and undesirable outcomes. Despite this, few studies have been conducted to investigate the efficacy and safety of stimulant therapy in treating ADHD in adults. As a consequence, drug treatment options for adult sufferers of ADHD are limited. The primary objective of this pilot, open-label study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (18, 36, 54 or 72 mg of methylphenidate hydrochloride, administered once-daily) in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD). Patients cannot have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit. Once deemed eligible, subjects will be started on 18 mg of CONCERTA® once-daily for 3 days, titrated up on Day 4 to 36 mg and maintained at this dose for 7 days. Depending on patient response, the dose of CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum of 72 mg per day, in order to achieve the optimal dose for each patient. The primary efficacy outcomes will be the changes from baseline to the end of treatment in the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CARRS). Safety and tolerability will be monitored throughout the study. The study hypothesis is that stimulant therapy in treating adult ADHD will be safe and effective, measured by the Conners' Adult ADHD Rating Scale (CAARS) score.
CONCERTA® is taken orally, once-daily. Starting with CONCERTA® 18 mg for 3 days, subjects are titrated up on Day 4 to 36 mg for 7 days. Depending on response, tolerability and clinician's discretion, the dose of CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum of 72 mg per day (two 36 mg tablets), until each subject's optimal dose is achieved. The titration period will last a maximum of 24 days.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Janssen-Ortho Inc., Canada
Published on BioPortfolio: 2014-08-27T03:47:57-0400
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 examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyp...
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) ...
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studi...
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity ...
Many children diagnosed with attention-deficit/hyperactivity disorder are treated with methylphenidate (MPH). The purpose of this study was to evaluate the relationship between long-term use of osmoti...
The effectiveness of psychostimulants, primarily methylphenidate (MPH), in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in the general population of typically growing children and ...
Much remains unclear about the benefits and harms of methylphenidate for children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Between 2012 and 2018, we conducted two Cochrane...
Disruptive mood dysregulation disorder (DMDD) is characterized by nonepisodic irritability and has a high rate of comorbidity with attention-deficit/hyperactivity disorder (ADHD). This is the first st...
We aimed to investigate the effectiveness and safety of methylphenidate (MPH), and especially its influence on seizures, in subjects with attention-deficit/hyperactivity disorder (ADHD) and epilepsy t...
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
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.
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.
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...
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 ...