Efficacy and tolerability of OROS methylphenidate in Korean children with attention-deficit/hyperactivity disorder
Soyoung Irene Lee1, Sungdo David Hong, Sang-Yeup Kim
1Department of Psychiatry, Soonchunhyang University Bucheon Hospital, College of Medicine, Soonchunhyang University, South Korea.
Insights
Concerta (OROS methylphenidate HCl) showed significant improvements in attention and behavior for Korean children with Attention-Deficit/Hyperactivity Disorder (AD/HD). This once-daily treatment was well-tolerated and effective in a four-week trial.
Area of Science:
- Pediatric Psychiatry
- Neurodevelopmental Disorders
- Pharmacology
Background:
- Attention-Deficit/Hyperactivity Disorder (AD/HD) is a common neurodevelopmental disorder in children.
- Effective pharmacological interventions are crucial for managing AD/HD symptoms.
- Concerta (OROS methylphenidate HCl) is a once-daily extended-release formulation of methylphenidate.
Purpose of the Study:
- To evaluate the efficacy and tolerability of initiating Concerta treatment in Korean children diagnosed with AD/HD.
- To assess the impact of Concerta on attention, behavior, and cognitive functions.
- To provide data supporting the use of once-daily methylphenidate in this pediatric population.
Main Methods:
- A multi-center, open-label, four-week trial involving 119 Korean children with AD/HD.
- Weekly dosage adjustments of Concerta based on symptom and safety assessments.
- Efficacy assessed using Parent and Teacher IOWA Conners Rating Scales, Peer Interaction Items, and Clinical Global Impression Scale.
- Cognitive function evaluated through tests including Continuous Performance Test and Trail Making Test.
Main Results:
- OROS methylphenidate was generally well-tolerated by the majority of participants.
- Significant improvements were observed in attention, behavior, and overall function, as reported by parents, teachers, and investigators.
- Cognitive tests also demonstrated benefits from the initiation of OROS methylphenidate treatment.
Conclusions:
- Initiation treatment with Concerta (OROS methylphenidate HCl) is safe and effective for Korean children with AD/HD in the short term.
- The once-daily methylphenidate preparation demonstrates significant behavioral and neuropsychological benefits.
- These findings support Concerta as a valuable treatment option for pediatric AD/HD in Korea.
Abstract:
This study evaluated the efficacy and tolerability in the initiation treatment of Concerta (OROS methylphenidate HCl) in Korean children with Attention-Deficit/Hyperactivity Disorder (AD/HD). One hundred and nineteen children with AD/HD were entered into a multi-center, open-label, four-week trial. The dosage of Concerta was adjusted by the investigators based on symptoms and safety assessments performed on a weekly basis. The safety of the drug and its efficacy for attention, behavior, and cognitive function were assessed. The primary outcome measures for efficacy were the Parent and Teacher IOWA Conners Rating Scales, Peer Interaction Items, and the Clinical Global Impression Scale. Cognitive tests (Continuous Performance Test, Matched Familiar Figure Test, Verbal Fluency Test, and Trail Making Test) were included as the secondary outcome measures. In most participants, OROS methylphenidate was well tolerated. There were significant improvements in attention, behavior, and function as measured by parents, teachers, and investigators. The benefit of the initiation of OROS methylphenidate in children with AD/HD was shown on the cognitive tests as well. These data provide support for the benefit of the once-daily methylphenidate preparation, Concerta in the treatment of Korean children with AD/HD. Children were initiated safely in this short-term trial, and its effectiveness was evident in the behavioral, as well as neuropsychological measurements.
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