Treatment of children with attention-deficit/hyperactivity disorder: results of a randomized, multicenter, double-blind, crossover study of extended-release dexmethylphenidate and D,L-methylphenidate and placebo in a laboratory classroom setting.

Abstract

The purpose of this study was to compare the efficacy and safety of extended-release dexmethylphenidate (d-MPH-ER) to that of d,l-MPH-ER and placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. This multicenter, double-blind, crossover study randomized 82 children, 6 to 12 years of age, stabilized on a total daily dose to the nearest equivalent of 40 to 60 mg of d,l-MPH or 20 or 30 mg/day of d-MPH. Patients participated in a screening day and practice day, and were randomized to 1 of 10 sequences of all five treatments in five separate periods. Treatments included d-MPH-ER (20 mg/day), d-MPH-ER (30 mg/day), d,l-MPH-ER (36 mg/day), d,l-MPH-ER (54 mg/day), and placebo. Primary efficacy was measured by the change from predose on the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale-Combined scores at 2-h postdose during the 12-h laboratory assessment (d-MPH-ER 20 mg/day vs. d,l-MPH-ER 36 mg/day). Adverse events were monitored throughout the study period. d-MPH-ER (20 mg/day) was significantly more effective than d,l-MPH-ER (36 mg/day) in the primary efficacy variable, change from predose to 2-h postdose in SKAMP-combined score. In general, d-MPH-ER had an earlier onset of action than d,l-MPH-ER, while d,l-MPH-ER had a stronger effect at 12-h postdose. No serious adverse events were reported. Treatment with either agent was associated with significant improvements in ADHD symptoms. d-MPH-ER and d,l-MPH-ER can be differentiated on what part of the day each is more effective.

• Authors: Raul Silva, Rafael Muniz, Kevin McCague, Ann Childress, Matthew Brams, Alice Mao
• Journal: Psychopharmacology bulletin (Psychopharmacol Bull) Vol. 41 Issue 1 Pg. 19-33 ( 2008) ISSN: 0048-5764 [Print] United States
• PMID: 18362868 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Central Nervous System Stimulants
• Delayed-Action Preparations
• Placebos
• Dexmethylphenidate Hydrochloride
• Methylphenidate

Topics

• Area Under Curve
• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Central Nervous System Stimulants (administration & dosage, adverse effects)
• Child
• Cross-Over Studies
• Delayed-Action Preparations
• Dexmethylphenidate Hydrochloride
• Double-Blind Method
• Female
• Humans
• Male
• Methylphenidate (administration & dosage, adverse effects)
• Placebos