Dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder
Raul R Silva1, Rafael Muniz2, Linda Pestreich2
1Dr. Silva is with the New York University Child Study Center; Drs. Muniz and Wang and Ms. Pestreich are with Novartis Pharmaceuticals; Dr. Brams is with Bayou City Research and with Baylor College of Medicine; Dr. Mao is with the Mental Health and Mental Retardation Authority of Harris County (Texas) and with the Baylor College of Medicine; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc..
Summary
Once-daily dexmethylphenidate extended release (D-MPH-ER) significantly improved ADHD symptoms in children over 12 hours. This ADHD medication demonstrated sustained efficacy in a laboratory classroom setting.
Area of Science:
- Pediatric Psychiatry
- Neuroscience
- Pharmacology
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Effective pharmacotherapy is crucial for managing ADHD symptoms and improving daily functioning.
- Dexmethylphenidate is a commonly prescribed stimulant medication for ADHD.
Purpose of the Study:
- To evaluate the efficacy and duration of action of once-daily dexmethylphenidate extended release (D-MPH-ER) in children with ADHD.
- To compare D-MPH-ER 20 mg/day with placebo over a 12-hour period in a controlled laboratory classroom setting.
Main Methods:
- A randomized, double-blind, placebo-controlled crossover study was conducted in children aged 6 to 12 with ADHD.
- Participants received D-MPH-ER 20 mg/day or placebo for 6 days, with crossover to the alternative treatment.
- Efficacy was assessed using the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score and academic tests over 12 hours.
Main Results:
- D-MPH-ER showed a significantly faster onset of action compared to placebo, with differences observed at 0.5 hours.
- Sustained improvements in SKAMP combined scores were observed from 0.5 to 12 hours post-dose (p < .001 to p = .013).
- Significant differences from placebo were noted across all measured time points for efficacy variables.
Conclusions:
- Once-daily D-MPH-ER provides sustained symptom control for children with ADHD throughout a 12-hour period.
- The medication demonstrated significant improvements in attention, behavior, and academic productivity.
- D-MPH-ER is an effective treatment option for managing ADHD symptoms in pediatric patients.
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