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

Sugrue, David; Bogner, Robin H.; Ehret, Megan J.

doi:10.2146/ajhp130638

Cited by 21 publications

(11 citation statements)

References 26 publications

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“…In the open-label, dose-optimization period, the most commonly reported TEAEs were consistent with those observed in children taking other MPH ER formulations for ADHD: decreased appetite, headache, abdominal pain, mood swings, irritability, and insomnia were among the most common AEs reported during the open-label, dose-optimization period of similarly designed studies of MPH ER capsule (Wigal et al 2014 ) and MPH ER oral suspension formulations (Robb et al 2014 ). AEs associated with MPH treatment generally occur early in treatment (Wolraich et al 2007 ; Sugrue et al 2014 ), and in the current study, fewer TEAEs were reported during the double-blind period, with similar percentages of subjects in the MPH ERCT and placebo groups reporting any AE. The most common TEAE reported during the double-blind period was URTI, reported by three subjects in each treatment group.…”

Section: Discussionsupporting

confidence: 65%

“…MPH was initially formulated as an immediate-release (IR) tablet requiring multiple daily doses for optimal treatment. Extended-release (ER) MPH formulations were later developed to provide all-day coverage, with the goal of eliminating the need for in-school administration, and to potentially increase efficacy and reduce adverse events (AEs) (Sugrue et al 2014 ). Several long-acting MPH formulations are currently available, including oral capsules and tablets (Concerta package insert 2015 ; Metadate CD package insert 2015 ; Ritalin LA package insert 2015), an oral suspension (Quillivant XR package insert 2016 ), and the transdermal patch (Daytrana package insert 2015 ).…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder

Wigal¹,

Childress

Berry

et al. 2017

Journal of Child and Adolescent Psychopharmacology

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Objective: 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-deficit/hyperactivity disorder (ADHD).Methods: Following a 6-week, open-label, dose-optimization period, children 6–12 years of age (n = 90) with ADHD were randomly assigned to double-blind MPH ERCT at the final optimized dose (20–60 mg/day) or placebo. After 1 week of double-blind treatment, efficacy was assessed predose and 0.75, 2, 4, 8, 10, 12, and 13 hours postdose in a laboratory classroom setting. The primary efficacy measure was the average of postdose Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale-Combined scores, analyzed using a mixed-model, repeated-measures analysis. Secondary efficacy measures included Permanent Product Measure of Performance (PERMP) total number of problems attempted and total number of problems correct. Safety assessments included adverse event (AE) monitoring and the Columbia-Suicide Severity Rating Scale (C-SSRS).Results: MPH ERCT treatment statistically significantly reduced the average of all postdose SKAMP-Combined scores versus placebo (least-squares mean difference [95% confidence interval], −7.0 [−10.9, −3.1]; p < 0.001). Statistically significant treatment differences in SKAMP-Combined scores were observed at 2 hours postdose through 8 hours postdose (p-values <0.001). Statistically significant differences between MPH ERCT and placebo in PERMP total number of problems attempted and total number of problems correct were observed at 0.75 hours postdose through 8 hours postdose (p-values ≤0.049). Common AEs in the open-label period (≥5%) were decreased appetite, upper abdominal pain, mood swings, irritability, insomnia, upper respiratory tract infection (URTI), dysgeusia, and headache; URTI was the only AE reported by >1 subject receiving MPH ERCT in the double-blind period (placebo: URTI, contusion, wound, and initial insomnia). No suicidal ideation or behavior was reported on the C-SSRS at baseline or at any postbaseline assessment.Conclusions: MPH ERCT 20–60 mg significantly improved ADHD symptoms compared with placebo at 2 hours postdose through at least 8 hours postdose. MPH ERCT was generally safe and well tolerated, with a safety profile consistent with other MPH ER formulations. Identifier: NCT01654250. .

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Section: Discussionsupporting

confidence: 65%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder

Wigal¹,

Childress

Berry

et al. 2017

Journal of Child and Adolescent Psychopharmacology

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“…Pharmacological treatment is considered effective and safe both for children and adults, but there is considerable inter-individual variability among patients regarding response to medication, required doses, and adverse events. Pharmacotherapy with methylphenidate (MPH) seems to be the first-line treatment of choice both in children 10, 11 and in adults 12, 13, 14, 15 with ADHD.…”

Section: Introductionmentioning

confidence: 99%

Attention-deficit hyperactivity disorder in adults: A systematic review and meta-analysis of genetic, pharmacogenetic and biochemical studies

2016

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The adult form of attention-deficit/hyperactivity disorder has a prevalence of up to 5% and is the most severe long-term outcome of this common disorder. Family studies in clinical samples as well as twin studies suggest a familial liability and consequently different genes were investigated in association studies. Pharmacotherapy with methylphenidate (MPH) seems to be the first-line treatment of choice in adults with attention-deficit hyperactive disorder (ADHD) and some studies were conducted on the genes influencing the response to this drug. Finally some peripheral biomarkers were identified in ADHD adult patients. We believe this work is the first systematic review and meta-analysis of candidate gene association studies, pharmacogenetic and biochemical (metabolomics) studies performed in adults with ADHD to identify potential genetic, predictive and peripheral markers linked specifically to ADHD in adults. After screening 5129 records, we selected 87 studies of which 61 were available for candidate gene association studies, 5 for pharmacogenetics and 21 for biochemical studies. Of these, 15 genetic, 2 pharmacogenetic and 6 biochemical studies were included in the meta-analyses. We obtained an association between adult ADHD and the gene BAIAP2 (brain-specific angiogenesis inhibitor 1-associated protein 2), even after Bonferroni correction, with any heterogeneity in effect size and no publication bias. If we did not apply the Bonferroni correction, a trend was found for the carriers allele 9R of dopamine transporter SLC6A3 40 bp variable tandem repeat polymorphism (VNTR) and for 6/6 homozygotes of SLC6A3 30 bp VNTR. Negative results were obtained for the 9-6 haplotype, the dopamine receptor DRD4 48 bp VNTR, and the enzyme COMT SNP rs4680. Concerning pharmacogenetic studies, no association was found for the SLC6A3 40 bp and response to MPH with only two studies selected. For the metabolomics studies, no differences between ADHD adults and controls were found for salivary cortisol, whereas lower serum docosahexaenoic acid (DHA) levels were found in ADHD adults. This last association was significant even after Bonferroni correction and in absence of heterogeneity. Other polyunsaturated fatty acids (PUFAs) such as AA (arachidonic acid), EPA (eicosapentaenoic acid) and DyLA (dihomogammalinolenic acid) levels were not different between patients and controls. No publication biases were observed for these markers. Genes linked to dopaminergic, serotoninergic and noradrenergic signaling, metabolism (DBH, TPH1, TPH2, DDC, MAOA, MAOB, BCHE and TH), neurodevelopment (BDNF and others), the SNARE system and other forty genes/proteins related to different pathways were not meta-analyzed due to insufficient data. In conclusion, we found that there were not enough genetic, pharmacogenetic and biochemical studies of ADHD in adults and that more investigations are needed. Moreover we confirmed a significant role of BAIAP2 and DHA in the etiology of ADHD exclusively in adults. Future research should be focused on the replication ...

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“…Methylphenidate half‐life is approx. 3 h in children and adolescents . The study was conducted in accordance with the Declaration of Helsinki and had been approved by the local Ethics committee.…”

Section: Methodsmentioning

confidence: 99%

Resting state default mode network connectivity in children and adolescents with ADHD after acute tryptophan depletion

Biskup

Helmbold

Baurmann

et al. 2016

Acta Psychiatr Scand

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

Cited by 21 publications

References 26 publications

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder

Attention-deficit hyperactivity disorder in adults: A systematic review and meta-analysis of genetic, pharmacogenetic and biochemical studies

Resting state default mode network connectivity in children and adolescents with ADHD after acute tryptophan depletion

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