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Lisdexamfetamine Dimesylate Improves Emotional Lability for Children With Attention-Deficit/Hyperactivity Disorder: Presented at AACAP

By Deborah Brauser

HONOLULU -- October 31, 2009 -- Lisdexamfetamine dimesylate (LDX) improves emotional lability (anger, irritability, and loss of temper) and symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged from 6 to 12 years, according to research presented at the American Academy of Child and Adolescent Psychiatry (AACAP) 56th Annual Meeting.

"Emotional lability -- marked by moods that go quickly up and down or distinct periods of irritability or euphoria -- has been estimated to affect 5% to 10% of the general population," explained lead author Ann Childress, MD, Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada, speaking during a poster session here on October 29. "Children with ADHD have a high incidence of emotional problems, and are more likely to have problems with emotional lability than those without the disorder."

In the original, double-blind, phase 3 efficacy trial of LDX, 290 children with ADHD were treated with either placebo (n = 72) or LDX in daily doses of 30 mg (n = 71), 50 mg (n = 74), or 70 mg (n = 73).

For this post hoc analysis, Dr. Childress and colleagues stratified the LDX-treated patients with a score greater than 3 (severe) on selected lability items from the Conners' Parent Rating Scale (CPRS) at baseline (prominent group, n = 138) and from those scoring 3 or less (not prominent, n = 73). The placebo group was also stratified into prominent (n = 41) and not prominent (n = 31) groups.

During the 4-week treatment period, the CPRS ratings were noted by parents and/or caregivers at 3 time points at baseline and during the day prior to each weekly visit. The investigators then evaluated efficacy by the changes in these scores between baseline to endpoint, as well as baseline-to-endpoint changes in the ADHD Rating Scale (RS)-IV Inattentive and Hyperactivity/Impulsivity subscale scores and in Clinical Global Impressions-Severity and Improvement ratings.

Additionally, the team evaluated the safety and tolerability of the study drug.

Results demonstrated that all children treated with LDX had significant improvements from baseline to endpoint in CPRS-derived emotional lability scores for all time points versus placebo (all P < .0005). The ADHD-RS-IV total, Inattentive, and Hyperactivity/Impulsivity scores and global symptom severity scores at endpoint also decreased in LDX groups regardless of CPRS-defined emotional lability at baseline.

Most treatment-related adverse events (97%) were reported as mild to moderate in severity and were deemed similar to those seen with long-acting stimulants. The adverse events in the treatment versus placebo groups, respectively, included the following: decreased appetite (39% vs 4%), insomnia (19% vs 3%), upper abdominal pain (12% vs 6%), headache (12% vs 10%), and irritability (10% vs 0%).

"Although there was a small group of parents reporting symptoms of side effects, most of the kids were actually getting better on the medicine versus placebo," noted Dr. Childress. "The vast majority had improved emotional lability scores on this medicine."

Funding for this study was provided by Shire Development Inc.

[Presentation title: The Effects of Lisdexamfetamine Dimesylate on Emotional Liability in Children 6-12 Years of Age With ADHD in a Double-Blind, Placebo-Controlled Trial. Abstract P-3.6]

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