Time course of treatment effect of OROS® methylphenidate in children with ADHD
Robert B Armstrong1, C V Damaraju, Steve Ascher
1Janssen Scientific Affairs, LLC, Raritan, NJ 08560, USA.
Insights
Osmotic-Release Oral System methylphenidate (OROS® MPH) effectively treated ADHD symptoms in children for over 12.5 hours. The treatment showed a robust effect starting at 1 hour post-dose.
Area of Science:
- Pediatric Psychiatry
- Pharmacology
- Neuroscience
Background:
- Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children.
- Methylphenidate is a widely prescribed stimulant medication for ADHD treatment.
- Understanding the pharmacokinetic and pharmacodynamic profile of OROS® MPH is crucial for optimizing treatment efficacy.
Purpose of the Study:
- To evaluate the time course of the treatment effect of Osmotic-Release Oral System methylphenidate (OROS® MPH) in children with ADHD.
- To determine the onset and duration of OROS® MPH's therapeutic effects in a controlled classroom setting.
Main Methods:
- Combined data from two double-blind, randomized, placebo-controlled, cross-over analog classroom studies.
- Children (9-12 years) with ADHD received individualized doses of placebo or OROS® MPH.
- Evaluated cognitive and behavioral outcomes at multiple time points (0.5 hr pre-dose to 12.5 hr post-dose) using standardized tests.
Main Results:
- Significant treatment effects of OROS® MPH were observed at all post-dose assessment time points (p < .0001).
- The therapeutic effect of OROS® MPH demonstrated a rapid onset, appearing by 1 hour post-dose.
- Adverse events associated with OROS® MPH were consistent with previous findings.
Conclusions:
- OROS® MPH provides a robust and sustained treatment effect for ADHD symptoms in children.
- The treatment's efficacy begins within 1 hour of administration and lasts for at least 12.5 hours.
- These findings support the use of OROS® MPH for long-acting symptom management in pediatric ADHD.
Objective:
The authors evaluated the time course of the treatment effect of Osmotic-Release Oral System methylphenidate (OROS(®) MPH) HCl (Concerta(®), Raritan, NJ) CII in children with ADHD.
Method:
Data were combined from two double-blind, randomized, placebo-controlled, cross-over, analog classroom studies in children (9-12 years) with ADHD. Participants received an individualized dose of placebo or OROS(®) MPH on two laboratory school days. Permanent Product Math Test and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores were evaluated 0.5 hr before dosing and 1, 2, 4, 10, 11, and 12.5 hr post dose. Analysis used a repeated-measures mixed model.
Results:
Treatment effects were present at all postdose assessment points (p < .0001 for all comparisons, n = 139). Adverse events were similar to previous reports for OROS(®) MPH.
Conclusion:
A robust treatment effect occurred with OROS(®) MPH; onset was at 1 hr and persisted for at least 12.5 hr after dosing.
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