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Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity

Laurence L Greenhill1, Rafael Muniz, Roberta R Ball

  • 1Research Unit of Pediatric Psychopharmacology at the New York State Psychiatric Institute, New York, NY 10032, USA. llg2@columbia.edu

Journal of the American Academy of Child and Adolescent Psychiatry
|July 13, 2006
PubMed

Insights

Dexmethylphenidate extended release (d-MPH-ER) effectively treated attention-deficit/hyperactivity disorder (ADHD) in pediatric patients. This ADHD medication demonstrated significant improvements compared to placebo.

Area of Science:

  • Pediatric Psychiatry
  • Neuroscience
  • Pharmacology

Background:

  • Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder in children and adolescents.
  • Effective management of ADHD symptoms is crucial for academic and social functioning.
  • Extended-release formulations aim to provide sustained symptom control with convenient dosing.

Purpose of the Study:

  • To evaluate the efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) versus placebo in pediatric patients diagnosed with ADHD.
  • To assess the impact of d-MPH-ER on core ADHD symptoms as measured by standardized rating scales.
  • To determine the overall clinical improvement and safety profile of d-MPH-ER in this population.

Main Methods:

  • A multicenter, randomized, double-blind, placebo-controlled, parallel-group study involving 97 pediatric patients (6-17 years) with DSM-IV-defined ADHD.
  • Patients received either d-MPH-ER or placebo for a 7-week treatment period, with flexible dosing up to 30 mg/day.
  • Primary efficacy endpoint was the change in the Conners ADHD/DSM-IV Scale-Teacher version (CADS-T) total score from baseline.

Main Results:

  • d-MPH-ER significantly improved CADS-T total scores compared to placebo (p <.001).
  • A higher percentage of patients on d-MPH-ER (67.3%) showed substantial improvement on the Clinical Global Impressions-Improvement scale versus placebo (13.3%) (p <.001).
  • Adverse events suspected as drug-related were reported more frequently in the d-MPH-ER group (49.1%) than the placebo group (25.5%).

Conclusions:

  • Once-daily administration of d-MPH-ER is an effective treatment for ADHD in children and adolescents.
  • d-MPH-ER demonstrates superior efficacy over placebo in reducing ADHD symptoms.
  • The safety profile of d-MPH-ER in this pediatric population warrants consideration in clinical practice.
Abstract

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