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| |  Lisdexamfetamine Dimesylate Preserves Appropriate Emotions in Children With ADHD: Presented at APA By Roberta Friedman, PhD SAN FRANCISCO -- May 21, 2009 -- Lisdexamfetamine dimesylate does not develop masking of emotions in children with attention-deficit/hyperactivity disorder (ADHD), according to a study presented here at the 162nd Annual Meeting of the American Psychiatric Association (APA). Alain Katic, MD, Claghorn Research Clinic, Bellaire, Texas, reported the post hoc analysis of a 7 week open-label trial at a poster presentation on May 18. The findings suggest that appropriate emotional expression can be preserved in children taking lisdexamfetamine dimesylate for ADHD, while inappropriate behaviour is controlled. Dr. Katic said that the drug treatment "did not make kids' mood and emotionality worse." The stimulant drugs have a reputation for producing a negative effect often characterised as "zombie-like" on emotional reactivity in children, he explained. The open-label design does have limitations, he conceded. Researchers tested lisdexamfetamine dimesylate 20 to 70 mg, optimised for each child. A total of 316 children were counted in the intent-to-treat analysis of the study (278 completed the trial). Primary endpoint for the trial had been rating on the ADHD Rating Scale. Percent improvement on this rating scale was 69.3% (P < .0001). The post hoc analysis was for all doses, using the Expression and Emotion Scale for Children (EESC) designed for assessing reaction to stimulant medication for ADHD. For the 304 children who had baseline and end of study measures, about one-third improved on emotional expression, rated by the EESC, and 9.2% showed worsening. Mean change from baseline was -7.4 (improved score, P <= .0001). Compared with baseline scores, changes of -2.1 occurred for positive emotions (P = .0002), and an improved score of -2.5 for emotional flatness (P<.0001). Emotional lability also improved (-2.8, P < .0001). Adverse reactions included decreased appetite, decreased weight, irritability, insomnia, headache, upper abdominal pain, affect lability, nausea, and vomiting. Funding for this study was provided by Shire Development Inc. [Presentation title: Improvement in Emotional Expression in Children With Attention-Deficit/Hyperactivity Disorder Treated With 20 to 70 Mg/Day Lisdexamfetamine Dimesylate. Abstract NR2-019]
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