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| |  Quetiapine Effective in Treating Bipolar Mania in Children: Presented at AACAP By Maria Bishop BOSTON, MA -- October 30, 2007 -- Quetiapine is significantly more effective than placebo in improving acute mania symptoms and overall functioning in children aged 10 to 17 years diagnosed with bipolar 1 mania, according to a short-term trial presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP). A 3-week, double-blind study of quetiapine randomised 284 children to quetiapine doses of either 400 mg/day (n = 93) or 600 mg/day (n = 95), or to placebo (n = 89), and reported significant improvements based on changes in the Young Mania Rating Scale (YMRS) scores from baseline. The study was led by Melissa DelBello, MD, Director, Child and Adolescent Psychiatry Division, Psychotic and Bipolar Disorder Research Program, and Co-Director, Mood Disorders Program, Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, United States. Efficacy assessments were made at baseline, days 4, 7, 14 and 21. Improvements were seen as early as day 4 in the lower-dose therapy arm and day 7 in the higher-dose therapy arm. Rates of response at day 21 showed YRMS score improvements of 64%, 58% and 37% for the 400-mg, 600-mg and placebo groups, respectively. Remission was defined as a total YMRS score of 12 or less, and was achieved by 53%, 54% and 30% of patients in the 400-mg, 600-mg and placebo groups, respectively. Safety findings were consistent with those observed in other quetiapine studies, Dr. DelBello observed. Younger patients demonstrated a higher incidence of particular adverse effects: increased appetite; increased pulse (and heart rate); syncope (three of four identified patients were aged 10-12); and suicidal ideas (five of seven identified patients were aged 10-12). Approximately 15% of this study population was receiving concomitant psychostimulants. In patients with potentially clinically important shifts in vital signs, there was a slightly higher incidence of psychostimulant use in the quetiapine groups compared with the placebo group. Treatment effects beyond 3 weeks warrant further investigation, the researchers noted. A 6-month, non-comparative, extension study is currently underway. Quetiapine is not approved by the United States Food & Drug Administration or any other national regulatory agency in the treatment of children with bipolar disorder. Funding for this study was provided by AstraZeneca Pharmaceuticals.
[Presentation title: Efficacy of Quetiapine in Children and Adolescents With Bipolar Mania: Abstract B10]
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