Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed | Szegedi et al. BMC Psychiatry 2011 11 101 http 1471-244X 11 101 BMC Psychiatry RESEARCH ARTICLE Open Access Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes a post hoc analysis of two 3-week clinical trials 1 1 2 11 3 Armin Szegedi Jun Zhao Arjen van Willigenburg Kari R Nations Mary Mackle and John Panagides Abstract Background Asenapine demonstrated superiority over placebo for mania in bipolar I disorder patients experiencing acute current manic or mixed episodes in 2 randomized placebo-and olanzapine-controlled trials. We report the results of exploratory pooled post hoc analyses from these trials evaluating asenapine s effects on depressive symptoms in patients from these trials with significant baseline depressive symptoms. Methods In the original trials A7501004 NCT00159744 A7501005 NCT00159796 977 patients were randomized to flexible-dose sublingual asenapine 10 mg twice daily on day 1 5 or 10 mg twice daily thereafter placebo or oral olanzapine 5-20 mg once daily for 3 weeks. Three populations were defined using baseline depressive symptoms 1 Montgomery-Asberg Depression Rating Scale MADRS total score 20 n 132 2 Clinical Global Impression for Bipolar Disorder-Depression CGI-BP-D scale severity score 4 n 170 3 diagnosis of mixed episodes n 302 by investigative site screening. For each population asenapine and olanzapine were independently compared with placebo using least squares mean change from baseline on depressive symptom measures. Results Decreases in MADRS total score were statistically greater with asenapine versus placebo at days 7 and 21 in all populations differences between olanzapine and placebo were not significant. Decreases in CGI-BP-D score were significantly greater with asenapine versus placebo at day 7 in all categories and day 21 in population 1 CGI-BP-D score reductions were significantly greater with olanzapine versus placebo at day 21 in .
