adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptoms辅助长效利培酮在双相情感障碍患者复发频繁,有活跃的情绪症状.pdfVIP

Macfadden et al. BMC Psychiatry 2011, 11:171 /1471-244X/11/171 RESEARCH ARTICLE Open Access Adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptoms 1 2 3 3 4 4* Wayne Macfadden , Caleb M Adler , Ibrahim Turkoz , John T Haskins , Norris Turner and Larry Alphs Abstract Background: The objective of this exploratory analysis was to characterize efficacy and onset of action of a 3- month treatment period with risperidone long-acting injection (RLAI), adjunctive to an individual’s treatment regimen, in subjects with symptomatic bipolar disorder who relapsed frequently and had significant symptoms of mania and/or depression. Methods: Subjects with bipolar disorder with ≥4 mood episodes in the past 12 months entered the open-label stabilization phase preceding a placebo-controlled, double-blind study. Subjects with significant depressive or manic/mixed symptoms at baseline were analyzed. Significant depressive symptoms were defined as Montgomery- Åsberg Depression Rating Scale (MADRS) ≥16 and Young Mania Rating Scale (YMRS) 16; manic/mixed symptoms were YMRS ≥16 with any MADRS score. Subjects received open-label RLAI (25-50 mg every 2 weeks) for 16 weeks, adjunctive to a subject’s individualized treatment for bipolar disorder (mood stabilizers, antidepressants, and/or anxiolytics). Clinical status was evaluated with the Clinical Global Impressions of Bipolar Disorder-Severity (CGI-BP-S) scale and changes on the MADRS and YMRS scales. Within-group changes were evaluated using paired t tests; categorical differences were assessed using Fisher exact test. No adjustment was made for multiplicity. Results: 162 subjects who r