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Frontiers in Psychiatry 2024To evaluate treatment responder rate using the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) score based on optimized dose level of...
OBJECTIVE
To evaluate treatment responder rate using the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) score based on optimized dose level of serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) and changes in ADHD severity in children (aged 6-12 years) with ADHD.
METHODS
During a 21-day dose-optimization phase, 155 patients initiated treatment with 39.2/7.8 mg SDX/d-MPH in the first week and then were titrated to an optimum dose; 5 patients were downtitrated to 26.1/5.2 mg, 76 were uptitrated to 52.3/10.4 mg, and 69 remained at 39.2/7.8 mg during the following 2 weeks. Responder threshold values were 30% and 50% based on the percent change from baseline (day 0) to days 7, 14, and 21 in the ADHD-RS-5 score. The Conners 3rd Edition-Parent score was used to assess weekly changes in ADHD severity during the dose-optimization and treatment phases.
RESULTS
Of the 5 subjects whose dose was optimized at 26.1/5.2 mg, ≥80% across all days had ≥50% responder rate. Of the 69 subjects whose dose was optimized at 39.2/7.8 mg, 81.2% had ≥50% responder rate by day 21. Of the 76 subjects whose dose was optimized to 52.3/10.4 mg, 72.4% had ≥50% responder rate by day 21. Changes in ADHD severity, based on mean Conners 3rd Edition-Parent scores, improved from baseline at each visit during dose optimization for each subscale. At the dose-optimization phase, Conners 3rd Edition-Parent scores improved from baseline for SDX/d-MPH in all subscales.
CONCLUSION
A high percentage of subjects were responders upon reaching their final optimized dose. SDX/d-MPH demonstrated significant reductions in ADHD severity in children based on the Conners 3rd Edition-Parent scores. Determining the optimal dosage of SDX/d-MPH and its effect on ADHD severity could enable the development of a more clinically relevant treatment regimen in children with ADHD.
PubMed: 38566957
DOI: 10.3389/fpsyt.2024.1310483 -
Developmental Neurorehabilitation Nov 2019This study evaluated the effects of dexmethylphenidate on problem behavior during functional analyses conducted across dexmethylphenidate and placebo conditions for a...
This study evaluated the effects of dexmethylphenidate on problem behavior during functional analyses conducted across dexmethylphenidate and placebo conditions for a child with multiple disabilities. We conducted functional analyses in a multielement format embedded in a withdrawal design and collected data on the frequency of disruptive behavior and duration of crying. Results suggest disruptive behaviour was maintained by attention when DMPH was absent, but not when it was present. Results also suggest DMPH may have had collateral effects on the probability of non-targeted behaviour (crying). Consistent with previous research, functional analyses exhibited a change in disruptive behaviour's function between medication and placebo conditions. These findings provide further support that stimulant medication may change the function of disruptive behavior and highlight the need to investigate the effects of stimulants on non-targeted behaviors.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Dexmethylphenidate Hydrochloride; Humans; Male; Problem Behavior
PubMed: 30632865
DOI: 10.1080/17518423.2019.1566279 -
Journal of Child and Adolescent... Nov 2021To evaluate the efficacy and safety of once-daily serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules (Azstarys) compared with placebo in children with... (Randomized Controlled Trial)
Randomized Controlled Trial
To evaluate the efficacy and safety of once-daily serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules (Azstarys) compared with placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a randomized, double-blind, dose-optimized laboratory classroom study. Children ages 6-12 with ADHD were enrolled. During a 3-week, open-label, Dose Optimization Phase, subjects initiated treatment with 39.2 mg/7.8 mg/day of SDX/d-MPH and were titrated weekly to an optimal dose (maximum dose of 52.3/10.4 mg). During the double-blind Treatment Phase, subjects were randomized to receive their optimal dose of SDX/d-MPH or placebo for 7 days. On day 7, efficacy was assessed in the laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). To evaluate safety, adverse events (AEs), vital signs, and electrocardiograms were assessed, and suicide risk was assessed. A total of 149 subjects completed the study. In the primary efficacy analysis, the mean postdose change from baseline in SKAMP-Combined scores averaged over the laboratory classroom day was significantly improved with SDX/d-MPH versus placebo (least-squares mean treatment difference [95% confidence interval]: -5.41 [-7.10 to -3.71]; < 0.001). A significant treatment effect for SDX/d-MPH compared with placebo was observed from 1 to 10 hours postdose. A analysis more comparable with that conducted in similar studies indicated a 0.5- to 13-hour onset and duration of efficacy. Both average postdose PERMP-Attempted and PERMP-Correct score changes from baseline were significantly improved among those treated with SDX/d-MPH versus placebo ( < 0.001 for both). No serious AEs were reported. During the Dose Optimization Phase, two-thirds of subjects reported AEs; the most common being insomnia and decreased appetite. SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6-12 years of age, with a rapid onset and extended duration of treatment effect. SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments.
Topics: Attention Deficit Disorder with Hyperactivity; Capsules; Central Nervous System Stimulants; Child; Delayed-Action Preparations; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Laboratories; Methylphenidate; Treatment Outcome
PubMed: 34714120
DOI: 10.1089/cap.2021.0077 -
PloS One 2021Patient access and adherence to chronic medications is critical. In this work, we evaluate whether disruptions related to Covid-19 have affected new and existing...
Patient access and adherence to chronic medications is critical. In this work, we evaluate whether disruptions related to Covid-19 have affected new and existing patients' access to pharmacological therapies without interruption. We do so by performing a retrospective analysis on a dataset of 9.4 billion US prescription drug claims from 252 million patients from May, 2019 through August, 2020 (about 93% of prescriptions dispensed within those months). Using fixed effect (conditional likelihood) linear models, we evaluate continuity of care, how many days of supply patients received, and the likelihood of discontinuing therapy for drugs from classes with significant population health impacts. Findings indicate that more prescriptions were filled in March 2020 than in any prior month, followed by a significant drop in monthly dispensing. Compared to the pre-Covid era, a patient's likelihood of discontinuing some medications increased after the spread of Covid: norgestrel-ethinyl estradiol (hormonal contraceptive) discontinuation increased 0.62% (95% CI: 0.59% to 0.65%, p<0.001); dexmethylphenidate HCL (ADHD stimulant treatment) discontinuation increased 2.84% (95% CI: 2.79% to 2.89%, p<0.001); escitalopram oxalate (SSRI antidepressant) discontinuation increased 0.57% (95% CI: 0.561% to 0.578%, p<0.001); and haloperidol (antipsychotic) discontinuation increased 1.49% (95% CI: 1.41% to 1.57%, p<0.001). In contrast, the likelihood of discontinuing tacrolimus (immunosuppressant) decreased 0.15% (95% CI: 0.12% to 0.19%, p<0.001). The likelihood of discontinuing buprenorphine/naloxone (opioid addiction therapy) decreased 0.59% (95% CI: 0.55% to 0.62% decrease, p<0.001). We also observe a notable decline in new patients accessing these latter two therapies. Most US patients were able to access chronic medications during the early months of Covid-19, but still were more likely to discontinue their therapies than in previous months. Further, fewer than normal new patients started taking medications that may be vital to their care. Providers would do well to inquire about adherence and provide prompt, nonjudgmental, re-initiation of medications. From a policy perspective, opioid management programs seem to demonstrate a robust ability to manage existing patients in spite of disruption.
Topics: Analgesics, Opioid; Antidepressive Agents; Antipsychotic Agents; COVID-19; Central Nervous System Stimulants; Contraceptive Agents, Hormonal; Datasets as Topic; Drug Prescriptions; Humans; Immunosuppressive Agents; Insurance, Pharmaceutical Services; Medication Adherence; Pandemics; Retrospective Studies; United States
PubMed: 33793663
DOI: 10.1371/journal.pone.0249453