In the article “A Randomized, Double-Blind Study of 30 Versus 20 mg Dexmethylphenidate Extended-Release in Children With Attention-Deficit/Hyperactivity Disorder” by Matthew Brams et al (J Clin Psychopharmacol. 2012;32:637–644), there were a series of omissions from the text of the abstract which may have caused confusion to readers. The correct text of the abstract is as follows:
The objective of this study was to evaluate the safety and efficacy of dexmethylphenidate extended-release (D-MPH-ER) 30 versus 20 mg in children with attention-deficit/hyperactivity disorder (ADHD) in a 12-hour laboratory classroom setting. In a randomized, double-blind, 3-period × 3-treatment, crossover study, children aged 6 to 12 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-diagnosed ADHD previously stabilized on MPH (40–60 mg/d) or D-MPH (20–30 mg/day) were randomized to receive D-MPH-ER 20 mg/day, 30 mg/day or placebo for 7 days each. Primary efficacy measurements were change in the average SKAMP-Combined score from predose to 10, 11, and 12 hours postdose [Avg(10–12)] between 30 mg and 20 mg D-MPH-ER. Safety was assessed by adverse events (AEs), vital sign monitoring, and ECGs. A total of 165 children were randomized and 162 included in the intent-to-treat analysis. Mean Avg (10–12) change from pre-dose in SKAMP-Combined score was significantly greater for D-MPH-ER 30 mg (–4.47) compared with D-MPH-ER 20 mg (–2.02; P = 0.002). Most common adverse events (≥3% in any group) were decreased appetite (6.1%, 4.9%, and 0%), headache (4.3%, 4.3%, and 1.9%), abdominal pain (3.7%, 3.1%, and 3.1%), and tachycardia (1.2%, 3.1%, and 0.6%) for D-MPH-ER 30 mg, D-MPH-ER 20 mg, and placebo, respectively). Significantly greater improvement in ADHD symptoms was noted with D-MPH-ER 30 mg compared with D-MPH-ER 20 mg at hours 10 through 12. Tolerability was comparable between doses. Dexmethylphenidate extended-release 30-mg dose may provide further benefit to patients who do not maintain optimal symptom control later in the day with D-MPH-ER 20 mg.
In addition, there was an important omission from the “Acknowledgments”. The correct text is as follows:
The authors thank Bonnie Brien of Novartis Pharmaceuticals, who assisted in the preparation of the first draft based on an author-approved outline and also assisted in implementing author revisions. Additional medical writing services were provided by Tim Blackstock, MB ChB, Medicus International, and funded by Novartis Pharmaceuticals. The authors also thank all participating study centers and principal investigators for their contributions to the conduct of the study: Andrew Cutler, MD, Brandenton, Fla; Alain Katic, MD, Houston, Tex; Americo Padilla, MD, South Miami, Fla; Bardley Vince, DO, Overland Park, Kans.
Other minor changes are:
Page 1, right column, paragraph 4, line 2: The trademark symbol should have been included after ‘SODAS’.
Page 7, paragraph 2, line 8: The words “a very recent” should have been “another”.
Brams M, Turnbow J, Pestreich L, et al.. A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate extended-release in children with attention-deficit/hyperactivity disorder: late-day symptom control
. J Clin Psychopharmacol
. 2012; 32 (5): 637–644.