Adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptoms

BMC Psychiatry

Research Article

Wayne Macfadden¹  Norris Turner²  Larry Alphs²  John T Haskins³  Ibrahim Turkoz³  Caleb M Adler⁴ 

[1] Formerly, Janssen Scientific Affairs, LLC, Titusville, NJ, USA;Janssen Scientific Affairs, LLC, Titusville, NJ, USA;Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA;University of Cincinnati College of Medicine, Cincinnati, OH, USA;

关键词: Depressive Symptom;    Bipolar Disorder;    Mood Stabilizer;    Young Mania Rate Scale;    Significant Depressive Symptom;   

DOI  :  10.1186/1471-244X-11-171

 received in 2010-12-20, accepted in 2011-10-28,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsSubjects 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.Results162 subjects who relapsed frequently met criteria for significant mood symptoms at open-label baseline; 59/162 (36.4%) had depressive symptoms, 103/162 (63.6%) had manic/mixed symptoms. Most subjects (89.5%) were receiving ≥1 medication for bipolar disorder before enrollment. Significant improvements were observed for the total population on the CGI-BP-S, MADRS, and YMRS scales (p < .001 vs. baseline, all variables). Eighty-two (53.3%) subjects achieved remission at the week 16 LOCF end point. The subpopulation with depressive symptoms at open-label baseline experienced significant improvement on the CGI-BP-S and MADRS scales (p < .001 vs. baseline, all variables). Subjects with manic/mixed symptoms at baseline had significant improvements on the CGI-BP-S and YMRS scales (p < .001 vs. baseline, all variables). No unexpected tolerability findings were observed.ConclusionsExploratory analysis of changes in overall clinical status and depression/mania symptoms in subjects with symptomatic bipolar disorder who relapse frequently showed improvements in each of these areas after treatment with RLAI, adjunctive to a subject's individualized treatment. Prospective controlled studies are needed to confirm these findings.

【 授权许可】

Unknown   
© Macfadden et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.