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

Robert L. Findling, Ronald L. Landbloom, Armin Szegedi, Janelle Koppenhaver, Sabine Braat, Qi Zhu, Mary Mackle, Kiki Chang, Maju Mathews

Research output: Contribution to journalArticlepeer-review

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.i.d., respectively. Treatment-emergent adverse events with an incidence ≥5% and at least twice placebo were somnolence, sedation, hypoesthesia oral, paresthesia oral, and increased appetite. The asenapine groups had a higher incidence of ≥7% weight gain (range, 8.0%-12.0%) versus placebo (1.1%; p <.05). The mean change from baseline in fasting insulin was larger for patients treated with asenapine than those with placebo (asenapine 2.5 mg b.i.d.: 73.375 pmol/L; asenapine 5 mg b.i.d.: 114.042 pmol/L; asenapine 10 mg b.i.d.: 59.846 pmol/L; placebo: 3.690 pmol/L). The mean changes from baseline for lipid parameters and glucose were also larger in asenapine groups than in the placebo group. No safety differences were observed with respect to ADHD and stimulant use. Conclusion All asenapine doses versus placebo were superior based on change in YMRS at day 21. Asenapine was generally well tolerated in patients aged 10 to 17 years with bipolar I disorder in manic or mixed states. Increases in weight and fasting insulin were associated with asenapine.

Original languageEnglish (US)
Pages (from-to)1032-1041
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume54
Issue number12
DOIs
StatePublished - 2015

Keywords

  • asenapine
  • bipolar I disorder
  • manic episode
  • mixed episode

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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