Development of a New Once-a-Day Formulation of Methylphenidate for the Treatment of Attention-deficit/Hyperactivity Disorder

Swanson, James M.; Gupta, Suneel; Lam, Andrew; Shoulson, Ira; Lerner, Marc; Modi, Nishit B.; Lindemulder, Elizabeth A.; Wigal, Sharon B.

doi:10.1001/archpsyc.60.2.204

Cited by 216 publications

(159 citation statements)

References 21 publications

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“…As expected and documented in the research literature (Pelham et al 2001;Swanson et al 2003), the primary efficacy endpoints that the PERMP and SKAMP measured at 4 hours were statistically significant for the comparison between OROS MPH and placebo. These results demonstrate improvement in classroom behaviors, productivity, attention to task, and other core symptoms of ADHD with OROS MPH.…”

Section: Discussionsupporting

confidence: 82%

“…Due to the large number of efficacy measures included in this study, investigators scheduled exploratory assessments during the time period when maximum drug effects would be expected based on previously conducted pharmacodynamic and pharmacokinetic studies (Pelham et al 2001;Swanson et al 2003). During the laboratory school day, there was also a need to balance the large number of academic measurements in this study with other components of the day, including meals and fun/recess activities, within a prolonged evaluation day in a young age group.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Wigal

Wigal²,

Schuck³

et al. 2011

Journal of Child and Adolescent Psychopharmacology

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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.

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Section: Discussionsupporting

confidence: 82%

Section: Outcome Measuresmentioning

confidence: 99%

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Wigal

Wigal²,

Schuck³

et al. 2011

Journal of Child and Adolescent Psychopharmacology

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“…Controlled-release MPH delivers methylphenidate via an osmotic pump to produce a smooth, ascending profile with duration of treatment effect through 12 hours. 15 Once-daily dosing of controlled-release MPH at 8 am is equivalent to thrice-daily MPH dosed at 8 am, 12 pm, and 4 pm. In this crossover design study, driving performance of ADHD-diagnosed adolescents (age range, 16 to 18 years) was assessed using a sophisticated driving simulator at 2 pm, 5 pm, 8 pm, and 11 pm Driving performance worsened by a factor of 5 at 8 pm and 11 pm when subjects received IR MPH.…”

mentioning

confidence: 99%

Controlled-Release Methylphenidate Improves Attention During On-Road Driving by Adolescents with Attention-Deficit/Hyperactivity Disorder

Cox

Humphrey²,

Merkel³

et al. 2004

The Journal of the American Board of Family Medicine

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Background: Attention-deficit/hyperactivity disorder (ADHD) is associated with a 3-to 4-fold increase in both driving-related accidents and associated injuries. Methylphenidate (MPH) is the most commonly prescribed psychostimulant medication for ADHD. It has been demonstrated to improve performance on a driving simulator. This study investigated whether a once-daily, long-acting, osmotic, controlledrelease MPH formulation improves the driving performance of ADHD adolescents while driving their own car on an actual road segment.Methods: Twelve ADHD-diagnosed male adolescent drivers (mean age, 17.8 years) prescribed a standard dose of 1.0 mg/kg (if they were not already taking methylphenidate) of controlled-release MPH participated in this repeated-measures crossover study. On 2 separate occasions (off/on medication randomized), participants drove a standard 16-mile road course incorporating rural, highway, and urban streets. A rater, blind to medication conditions, sat in the back seat and rated impulsive (eg, "cutting off" another driver) and inattentive (eg, drove past designated turn) driving errors.Results: Impulsive driving errors were observed to occur rarely under both medication and no medication conditions. Inattentive driving errors were more common and were significantly reduced while the subject was on medication (4.6 versus 7.8; P < .01). The improvement in driving performance (change in number of errors recorded) from first to second testing was positively correlated with medication dosage (r ‫؍‬ 0.60; P < .01). Conclusions

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“…Earlier studies have demonstrated the onset of action of OROS methylphenidate to be 1 hour post dose, with length of activity of no more than 12 hours [8][9][10][11] . The time to peak plasma concentration has been found to be 6.8±1.8 hours.…”

Section: Discussionmentioning

confidence: 99%

Chin Trembling Induced by Combined Use of OROS Methylphenidate and Procaterol Hydrochloride in a Boy with ADHD

Yang

Jundong²,

Zhang

et al. 2014

Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychophar

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ABS TRACT:Chin trembling induced by combined use of OROS methylphenidate and procaterol hydrochloride in a boy with ADHD Recently, asthma has been reported to be a potential comorbidity of attention deficit hyperactivity disorder (ADHD). It is, therefore, possible to have combined use of medications for both ADHD and asthma although, potential adverse reactions are unknown. The case presented here is that of a 61/2-year-old boy diagnosed as having both ADHD and asthma. He presented with chin trembling after the first administration of OROS methylphenidate and procaterol hydrochloride. This is the first report of an adverse event in patients using a combination of these two types of drugs. It raises an awareness of chin trembling as an adverse effect in patients using a combination of methylphenidate and procaterol hydrochloride, especially among those who are younger and underweight.Keywords: attention-deficit/hyperactivity disorder (ADHD), asthma; adverse effect, OROS methylphenidate, procaterol hydrochloride Bulletin of Clinical Psychopharmacology 2014;24(2):168-71

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Development of a New Once-a-Day Formulation of Methylphenidate for the Treatment of Attention-deficit/Hyperactivity Disorder

Cited by 216 publications

References 21 publications

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Controlled-Release Methylphenidate Improves Attention During On-Road Driving by Adolescents with Attention-Deficit/Hyperactivity Disorder

Chin Trembling Induced by Combined Use of OROS Methylphenidate and Procaterol Hydrochloride in a Boy with ADHD

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Development of a New Once-a-Day Formulation of Methylphenidate for the Treatment of Attention-deficit/Hyperactivity Disorder

Cited by 216 publications

References 21 publications

Academic, Behavioral, and Cognitive Effects of OROS® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Academic, Behavioral, and Cognitive Effects of OROS® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Controlled-Release Methylphenidate Improves Attention During On-Road Driving by Adolescents with Attention-Deficit/Hyperactivity Disorder

Chin Trembling Induced by Combined Use of OROS Methylphenidate and Procaterol Hydrochloride in a Boy with ADHD

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Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder