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Optimization of Methylphenidate Extended-Release Chewable Tablet Dose in Children with ADHD: Open-Label Dose
Sharon B Wigal1, Ann Childress2, Sally A Berry3
11 University of California Irvine , Irvine, California.
Journal of Child and Adolescent Psychopharmacology
|April 12, 2018
Summary
Methylphenidate extended-release chewable tablets (MPH ERCT) effectively reduced attention-deficit/hyperactivity disorder (ADHD) symptoms in children aged 6-12. Dose optimization led to significant symptom score improvements over six weeks.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Psychiatry
- Clinical Trial Research
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Methylphenidate extended-release chewable tablets (MPH ERCT) offer a flexible dosing option for pediatric ADHD management.
- Optimizing MPH ERCT dosage is crucial for maximizing efficacy and tolerability in young patients.
Purpose of the Study:
- To evaluate dose patterns, ADHD symptom reduction, and safety of MPH ERCT during a 6-week dose-optimization period.
- To analyze the relationship between optimized MPH ERCT dosage and ADHD symptom severity in children.
- To provide data for clinicians on effective MPH ERCT dose titration strategies.
Main Methods:
- A 6-week, open-label, phase 3 study involving boys and girls (6-12 years) with ADHD.
- Participants initiated MPH ERCT at 20 mg/day, with weekly titration based on efficacy and tolerability (max 60 mg/day).
- ADHD symptom severity was assessed using the ADHD Rating Scale (ADHD-RS-IV); adverse events were recorded.
Main Results:
- Mean MPH ERCT dose increased from 29.4 mg/day at week 1 to 42.8 mg/day at week 5.
- Significant reduction in mean ADHD-RS-IV total scores from 40.1 at baseline to 12.4 at week 5.
- 72.2% of participants experienced treatment-emergent adverse events during the dose-optimization phase.
Conclusions:
- Dose optimization of MPH ERCT in children with ADHD led to substantial symptom improvement.
- The study provides valuable insights into MPH ERCT dose-response relationships for clinical practice.
- Further analysis of dose-optimization data can guide individualized MPH ERCT treatment regimens.
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