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Teachers Report Improvement in Children With Attention-Deficit Hyperactivity Disorder Taking Dexmethylphenidate: Presented at AACAP

By Maria Bishop

BOSTON, MA -- October 26, 2007 -- Children with attention-deficit hyperactivity disorder (ADHD) who are treated with dexmethylphenidate extended release (ER) showed significant improvements in their scores on teacher-rated scales for inattention, hyperactivity and impulsivity, according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP).

A randomised, placebo-controlled study of dexmethylphenidate ER at doses up to 30 mg/day reported improved performance from baseline to completion of treatment at 5 weeks compared with placebo.

Performance was primarily evaluated using the Conners ADHD Rating Scale - Teacher (CADS-T). A secondary evaluation focused on the CADS-T Inattentive and Hyperactivity/Impulsive subscales, noted lead author Ann Childress, MD, Psychiatrist, Center for Psychiatric and Behavioral Medicine, Inc., Las Vegas, Nevada, United States, who presented results here on October 25.

After a 1- to 4-week washout screening phase (depending on previous medication), 253 children aged 6 to 12 years were randomised to placebo or one of three dexmethylphenidate ER regimens (1:1:1:1 ratio): 30 mg/day; 20 mg/day; or 10 mg/day. Patients were titrated upwards from 5 mg/day in week 1, and increased weekly by 10 mg/day depending on the treatment arm.

The efficacy analysis was performed on 240 patients using an analysis of covariance (ANCOVA) model that included centre and baseline scores as well as the fixed effects of the treatment group. Significant improvements (P <.001) were shown as adjusted mean changes (20-point changes and higher) in each treatment group from baseline in CADS-T total subscale. Adjusted mean changes in the placebo group represented a 5-point change. The highest adjusted mean changes were seen in the 30-mg treatment group.

Higher adverse-event rates were noted for the methylphenidate groups compared with placebo in the areas of metabolic/nutritional and psychiatric adverse effects (18% vs 5% and 25% vs 8%, respectively). These findings were not unexpected in stimulants, according to the researchers.

Baseline demographics and characteristics were comparable between all groups.

Funding for this study was provided by Novartis Pharmaceuticals Corporation.


[Presentation title: Fixed-Dose Titration Study of Dexmethylphenidate Extended Release in Children With ADHD: Effects on Teacher-Rated Scales. Abstract B55]

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