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| |  Children With Attention-Deficit Hyperactivity Disorder Taking Atomoxetine Do Not Experience Delayed Sexual Development: Presented at AACAP By Maria Bishop BOSTON, MA -- October 26, 2007 -- Atomoxetine was not associated with a failure to mature sexually in children taking the drug for attention-deficit hyperactivity disorder (ADHD), according to study results presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP). This finding is consistent with previous preclinical studies, the researchers noted. In the study, subjects' age at puberty onset was consistent with United States norms. All subjects had confirmed ADHD and were aged 6 to 15 years old. The 18-month trial began with 10 weeks of open-label treatment with atomoxetine. Patients who met response criteria entered a 15-month, double-blind trial where they were randomised to treatment or placebo. Overall, 382 of 500 the subjects were assessed at the end of the trial, led by Thomas Spencer, MD, Assistant Director, Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, Massachusetts, United States. Patients were assessed for Tanner stages (evaluating secondary sex characteristics) at study entry, at 6 months, 12 months and 18 months. The distribution of the number of days to first increase in Tanner stage was estimated for each treatment group using the Kaplan-Meier product limit estimator. The age of puberty onset was a mean of 12.1 years for placebo patients (n = 78) and 12.5 years for atomoxetine patients (n = 184). No statistically significant differences were observed between the atomoxetine and the placebo groups for the following: proportion of patients who had at least one Tanner-stage change; distribution of time to first Tanner-stage change; and proportion of patients in each baseline Tanner stage group moving to higher stages. The fact that the placebo group had a 3-month exposure to atomoxetine is a study limitation, but the authors noted that it seems unlikely it would have had further effects on sexual development after discontinuation.
[Presentation title: Effects of Atomoxetine on Sexual Development in Children and Adolescents With Attention-Deficit Hyperactivity Disorder. Abstract B01]
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