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BMC Psychiatry. 2011; 11: 101.
Published online Jun 20, 2011. doi:  10.1186/1471-244X-11-101
PMCID: PMC3152513
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
Armin Szegedi,corresponding author1 Jun Zhao,1 Arjen van Willigenburg,2 Kari R Nations,1 Mary Mackle,1 and John Panagides3
1Merck Research Laboratories, Rahway, NJ, USA
2At Time of Research: Schering-Plough (formerly Organon), Roseland, NJ, USA
3At Time of Research: Schering-Plough (formerly Organon), now Merck Research Laboratories, Summit, NJ, USA
corresponding authorCorresponding author.
Armin Szegedi: armin.szegedi/at/merck.com; Jun Zhao: jun.zhao/at/merck.com; Arjen van Willigenburg: a.vanwilligenburg/at/hotmail.com; Kari R Nations: kari.nations/at/merck.com; Mary Mackle: mary.mackle/at/merck.com; John Panagides: jpanagides/at/yahoo.com
Received December 21, 2010; Accepted June 20, 2011.
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 population 1 and day 7 in populations 2 and 3.
Conclusions
These post hoc analyses show that asenapine reduced depressive symptoms in bipolar I disorder patients experiencing acute manic or mixed episodes with clinically relevant depressive symptoms at baseline; olanzapine results appeared to be less consistent. Controlled studies of asenapine in patients with acute bipolar depression are necessary to confirm the generalizability of these findings.
Keywords: asenapine, bipolar I disorder, depressive symptoms, post hoc analysis
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