Efficacy and safety of extended-release dexmethylphenidate compared with d,l-methylphenidate and placebo in the treatment of children with attention-deficit/hyperactivity disorder: a 12-hour laboratory classroom study.

Abstract

OBJECTIVE:

This study compared the efficacy and safety of extended-release dexmethylphenidate (d-MPH-ER) 20 mg/day and 30 mg/day with extended-release racemic methylphenidate hydrochloride (d,l-MPH-ER) 36 mg/day and 54 mg/day, and placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.

METHODS:

This multicenter, double-blind, crossover study included children (N = 84) 6-12 years of age, stabilized on total daily doses of 40 mg to 60 mg d,l-MPH or 20 mg/day or 30 mg/day d-MPH who were randomized to different treatment sequences. Primary efficacy was measured by the change from pre-dose in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale-Combined scores at 2 hours post-dose (d-MPH-ER 20 mg/day versus d,l-MPH- ER 36 mg/day). Adverse events were monitored throughout the study period.

RESULTS:

Mean change in SKAMP-Combined score at 2 hours post-dose was significantly larger for d-MPH-ER 20 mg/day versus d,l-MPH-ER 36 mg/day (p < 0.001). Both doses of d-MPH-ER had a more rapid onset and greater morning effect relative to d,l-MPH-ER while d,l-MPH-ER had a greater effect at the end of the 12-hour day. All active treatments provided a significant benefit over placebo at most time points to 12 hours post-dosing. Both treatments were well tolerated.

CONCLUSIONS:

d-MPH-ER and d,l-MPH-ER improved ADHD symptoms and were well tolerated. While d-MPH-ER had a faster onset of action, d,l-MPH-ER retained greater effect at the end of the 12- hour classroom day.

• Authors: Rafael Muniz, Matthew Brams, Alice Mao, Kevin McCague, L Pestreich, Raul Silva
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 18 Issue 3 Pg. 248-56 (Jun 2008) ISSN: 1557-8992 [Electronic] United States
• PMID: 18582179 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Delayed-Action Preparations
• Placebos
• Dexmethylphenidate Hydrochloride
• Methylphenidate

Topics

• Attention Deficit Disorder with Hyperactivity (drug therapy, psychology)
• Chemistry, Pharmaceutical
• Child
• Cross-Over Studies
• Delayed-Action Preparations
• Dexmethylphenidate Hydrochloride
• Double-Blind Method
• Drug Administration Schedule
• Female
• Headache (chemically induced, psychology)
• Humans
• Male
• Methylphenidate (administration & dosage, adverse effects, chemistry)
• Placebos
• Schools
• Social Environment
• Time Factors
• Treatment Outcome