Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to &lt;6 Years

Childress, Ann; Foehl, Henry C.; Newcorn, Jeffrey H.; Faraone, Stephen V.; Levinson, Benjamin; Adjei, Akwete

doi:10.1016/j.jaac.2021.03.019

Cited by 11 publications

(8 citation statements)

References 40 publications

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“…In a 1-year study of an MPH multilayer release (MPH-MLR) extended-release formulation in children aged 4–6 years with ADHD, 65 of 89 subjects (73%) experienced TEAEs, and 11.2% discontinued treatment because of an AE (Childress et al, 2022 ). The most commonly reported AE was decreased weight in 18% of subjects.…”

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study

Childress

Marraffino²,

Cutler

et al. 2023

Journal of Child and Adolescent Psychopharmacology

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Objective: Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) is approved for the treatment of patients aged ≥6 years with attention-deficit/hyperactivity disorder (ADHD). A pivotal double-blind (DB) study of children aged 6–12 years with ADHD demonstrated efficacy for ADHD with good tolerability. In this study, we assessed the safety and tolerability of daily oral SDX/d-MPH for up to 1 year in children with ADHD. Methods: This was a dose-optimized, open-label safety study with SDX/d-MPH in children aged 6–12 years with ADHD that included subjects who successfully completed the DB study (rollover) and new subjects. The study consisted of a 30-day screening phase, a dose optimization phase for new subjects only, a 360-day treatment phase, and follow-up. Adverse events (AEs) were assessed from the first day of SDX/d-MPH administration to the end of the study. During the treatment phase, ADHD Rating Scale-5 (ADHD-RS-5) and Clinical Global Impressions–Severity (CGI-S) scale assessments were used to evaluate ADHD severity. Results: Of the 282 subjects enrolled (70 rollover; 212 new), 28 discontinued treatment in the dose optimization phase and 254 entered the treatment phase. By study completion, 127 had discontinued and 155 had completed the study. The treatment-phase safety population included all enrolled subjects who received ≥1 dose of study drug and had ≥1 postdose safety assessment. Of 238 subjects assessed in the treatment-phase safety population, 143 (60.1%) had ≥1 treatment-emergent adverse events (TEAEs), and 36 (15.1%), 95 (39.9%), and 12 (5.0%) had mild, moderate, or severe TEAEs, respectively. The most common TEAEs were decreased appetite (18.5%), upper respiratory tract infection (9.7%), nasopharyngitis (8.0%), decreased weight (7.6%), and irritability (6.7%). There were no clinically meaningful trends in electrocardiograms, cardiac events, or blood pressure events, and none led to discontinuation. Two subjects had eight serious AEs that were unrelated to treatment. There were overall reductions in ADHD symptoms and severity as assessed by ADHD-RS-5 and CGI-S during the treatment phase. Conclusions: In this 1-year study, SDX/d-MPH was found to be safe and well tolerated and comparable with other methylphenidate products, with no unexpected safety findings. SDX/d-MPH also showed sustained efficacy during the 1-year treatment period. identifier: NCT03460652.

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Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study

Childress

Marraffino²,

Cutler

et al. 2023

Journal of Child and Adolescent Psychopharmacology

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“…Moreover, the mean weight gain reported in the above trials may not reflect the actual risks associated with antipsychotic monotherapy in children or adolescents. Many of the trial participants were receiving concurrent stimulant therapy, which is associated with reduced appetite and possible weight loss, particularly in younger children [ 67 ]. The observation that around one quarter of trial participants gained over 5% of their baseline body weight over a longer treatment period is a cause for greater concern, though this figure was based on a single trial and requires replication [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Antipsychotics in the Management of Disruptive Behavior Disorders in Children and Adolescents: An Update and Critical Review

Rajkumar

2022

Biomedicines

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Disruptive behaviour disorders (DBDs) in childhood include conduct disorder (CD) and oppositional defiant disorder (ODD). Though psychological therapies are considered to be the first-line treatment for DBDs, many patients require adjunctive pharmacotherapy for the control of specific symptoms, such as aggression. Three prior systematic reviews have examined the evidence for the use of antipsychotics in DBDs and have concluded that their efficacy is marginal and limited by adverse effects. This paper has two objectives: (i) to summarize the findings of existing systematic reviews of antipsychotics for the management of DBDs in children and adolescents (2012–2017), and (ii) to provide an update to these reviews by examining recent clinical trials of antipsychotics in this population, published in the period from 2 January 2017 to 10 October 2022. The PubMed, Scopus and ScienceDirect databases were searched for relevant citations using the search terms “disruptive behaviour disorder”, “oppositional defiant disorder”, “conduct disorder” and their variants, along with “antipsychotic”, “atypical antipsychotic” and the generic names of all currently approved atypical antipsychotics. Six relevant trials were identified during this period, including five randomized controlled trials and one naturalistic open-label trial. These trials were critically evaluated in terms of outcome measures, efficacy and safety. Overall, the data from these trials suggests that of all available antipsychotics, risperidone appears to be effective in the short-term management of DBDs. All available antipsychotics are associated with significant metabolic adverse effects in this population. These results are discussed in the light of global trends towards increasing off-label prescription of antipsychotic medication in children and adolescents and of recent literature on the neuropharmacology of aggression in this patient population. The need for rational, short-term use of these drugs is highlighted, as well as the importance of post-marketing surveillance for long-term or severe adverse events.

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“…Schrantee et al classified patients with ADHD according to the time of drug initiation [ 43 ]. Also, several studies classified short-term and long-term based on one year [ 22 , 23 , 40 ]. Likewise, we compared ADHD patients by dividing them into short-term and long-term groups based on one year.…”

Section: Discussionmentioning

confidence: 99%

“…To verify their first exposure to MPH treatment, we excluded patients who had been enrolled in the database for less than 1 year before MPH treatment. Patients were divided into two groups according to the time of MPH initiation: long-term and short-term MPH treatment groups [ 22 , 23 ]. Long-term MPH treatment was defined as continuous MPH exposure since 2017, indicating an MPH exposure of at least 365 days and less than 730 days.…”

Section: Methodsmentioning

confidence: 99%

Long-term methylphenidate use for children and adolescents with attention deficit hyperactivity disorder and risk for depression, conduct disorder, and psychotic disorder: a nationwide longitudinal cohort study in South Korea

Park

Lee

Kim

et al. 2022

Child Adolesc Psychiatry Ment Health

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Background Methylphenidate (MPH) is the most frequently prescribed medication for the treatment of attention deficit hyperactivity disorder (ADHD). However, the safety of its long-term use remain unclear. In particular, real-world evidence of long-term MPH treatment regarding the risk of depression, conduct disorders, and psychotic disorders in children and adolescents is needed. This study aimed to compare the risks of depression, conduct disorder, and psychotic disorder between long- and short-term MPH treatments in children and adolescents. Methods This population-based cohort study used a nationwide claims database of all patients with ADHD in South Korea. Patients aged less than 18 years who were prescribed MPH were included in the study. Long- and short-term MPH were defined as > 1 year, and < 1 year, respectively. Overall, the risk of developing depressive disorder, conduct disorder and oppositional defiant disorder (ODD), and psychotic disorder were investigated. A 1:2 propensity score matching was used to balance the cohorts, and the Cox proportional hazards model was used to evaluate the safety of MPH. Results We identified 1309 long-term and 2199 short-term MPH users. Long-term MPH use was associated with a significantly lower risk of depressive (hazard ratio [HR], 0.70 [95% confidence interval [CI] 0.55–0.88]) and conduct disorders and ODD (HR, 0.52 [95% CI 0.38–0.73]) than short-term MPH use. Psychotic disorder was not significantly associated with long-term MPH use (hazard ratio [HR], 0.83 [95% confidence interval [CI] 0.52–1.32]). Conclusions Our findings suggest that long-term MPH use may be associated with a decreased risk of depression, conduct disorders and ODD. Moreover, the long-term use of MPH does not increase the risk of psychotic disorders. Long-term MPH administration may be considered as a favourable treatment strategy for children and adolescents with ADHD regarding depressive, conduct, and psychotic disorders.

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Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years

Cited by 11 publications

References 40 publications

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study

Antipsychotics in the Management of Disruptive Behavior Disorders in Children and Adolescents: An Update and Critical Review

Long-term methylphenidate use for children and adolescents with attention deficit hyperactivity disorder and risk for depression, conduct disorder, and psychotic disorder: a nationwide longitudinal cohort study in South Korea

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