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Psych Congress  

Efficacy of Asenapine in Relation to the Number of Prior Manic/Mixed Episodes in Pediatric Patients With Bipolar I Disorder

Roger McIntyre, MD; Robert Findling, MD; Xiao Wu, PhD; John Edwards, MD; Willie Earley, MD; Chris Gache, MD
Allergan, Inc

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Asenapine monotherapy is approved for pediatric patients aged 10-17 for acute treatment of manic or mixed episodes associated with bipolar I disorder (BD). This post hoc analysis examined the efficacy of asenapine in pediatric patients with BD according to the number of prior manic/mixed episodes experienced.
Data were obtained from a 3-week, double-blind, placebo-controlled, parallel-group trial in pediatric patients (10-17 years) with BD (NCT01244815). Patients randomized (1:1:1:1) to placebo or asenapine 2.5 mg, 5 mg, or 10 mg twice daily were categorized by the number of prior manic/mixed episodes. Change from baseline to day 21 in Young Mania Rating Scale (YMRS) and Clinical Global Impressions-Bipolar (CGI-BP) total scores total score was analyzed using a mixed model for repeated measures.
The least squares mean differences (LSMDs) were statistically significant in favor of asenapine versus placebo on YMRS total score for all doses in patients with <3 prior episodes (2.5 mg [n=36]: -3.8, P=.0347; 5 mg [n=38]: −3.9, P=.0279; 10 mg [n=28]: −4.7, P=.0152), for 5 mg and 10 mg in patients with 3-5 prior episodes (5 mg [n=19]: −10.2, P=.0002; 10 mg [n=20]: −7.7, P=.0043), and for 2.5 mg and 10 mg in patients with >5 prior episodes (2.5 mg [n=10]: -8.4, P=.0228; 10 mg [n=12]: −11.6, P=.0007). Changes in CGI-BP total score followed a similar pattern.
In conclusion, asenapine is effective in pediatric patients with BD experiencing a manic or mixed episode regardless of prior episode status; however, small sample sizes preclude definitive conclusions about differences by dose.

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