Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar i Disorder

Abstract

Objective To evaluate asenapine versus placebo in 403 patients aged 10 to 17 years with bipolar I disorder currently in manic or mixed episodes. Method In this double-blind, placebo-controlled, international trial, patients were randomized 1:1:1:1 to placebo, asenapine 2.5, 5, or 10 mg b.i.d. (twice daily). Primary efficacy measure was change from baseline in Young-Mania Rating Scale (YMRS) total score at day 21. Analyses of patients with/without attention-deficit/hyperactivity disorder (ADHD) and with/without stimulant use were performed. Results The mean difference in asenapine versus placebo in YMRS was -3.2 (p =.0008), -5.3 (p <.001), and -6.2 (p <.001) for asenapine 2.5, 5, and 10 mg b...