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Logo of bmcpsycBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Psychiatry
BMC Psychiatry. 2011; 11: 171.
Published online Oct 28, 2011. doi:  10.1186/1471-244X-11-171
PMCID: PMC3219580
Adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptoms
Wayne Macfadden,1 Caleb M Adler,2 Ibrahim Turkoz,3 John T Haskins,3 Norris Turner,4 and Larry Alphscorresponding author4
1Formerly, Janssen Scientific Affairs, LLC, Titusville, NJ, USA
2University of Cincinnati College of Medicine, Cincinnati, OH, USA
3Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA
4Janssen Scientific Affairs, LLC, Titusville, NJ, USA
corresponding authorCorresponding author.
Wayne Macfadden: drwaynemacf/at/; Caleb M Adler: Adlercb/at/; Ibrahim Turkoz: ITurkoz/at/; John T Haskins: THaskin2/at/; Norris Turner: NTurner1/at/; Larry Alphs: LAlphs/at/
Received December 20, 2010; Accepted October 28, 2011.
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.
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.
162 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.
Exploratory 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.
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