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Asenapine Found to Be Safe, Effective in Youth With Manic or Mixed Episode of Bipolar I Disorder
The second-generation antipsychotic asenapine may help to reduce mania and the severity of illness in youth with bipolar I disorder within days, according to a
published in the December issue of the
Journal of the American Academy of Child and Adolescent Psychiatry
Robert Findling, M.D. (pictured left), the director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University School of Medicine, and colleagues randomly assigned 403 youth (aged 10 to 17) displaying manic or mixed episodes of bipolar I disorder to receive placebo or asenapine (2.5 mg, 5 mg, or 10 mg) twice daily for three weeks.
The researchers found that all three doses of asenapine led to statistically significant improvements in Young-Mania Rating Scale (YMRS) scores and Clinical Global Impression scale for use in Bipolar Illness (CGI-BP) from days 4 and 7 onward. By day 21, a positive drug response (greater than 50% reduction in YMRS scores from baseline) was achieved by 42% to 54% of those taking asenapine compared with 28% among youth taking placebo. There were no significant differences in YMRS total score between the asenapine groups versus the placebo group in patients with and without attention-deficit/hyperactivity disorder, with and without concomitant stimulant use, or with respect to age and gender.
The incidence of clinically significant weight gain at 21 days was statistically significant versus that of placebo in...
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