Source: DGNews  |  Posted 2 years ago

By Jill Stein

PARIS -- July 2, 2009 -- Asenapine and olanzapine lessen the severity of acute manic symptoms in patients with bipolar 1 disorder who have either manic or mixed episodes, researchers reported on July 2 here at the 9th World Congress of Biological Psychiatry (WCBP).

Roger McIntyre, MD, University of Toronto, Toronto, Ontario, and colleagues assessed the efficacy of asenapine in treating mania in subpopulations of patients with bipolar 1 disorder diagnosed with either manic episodes or mixed states.

The group used pooled data from 2 similar 3-week trials in which patients were randomised to sublingual asenapine 10 mg BID on day 1 (flexible 5 or 10 mg BID thereafter), oral olanzapine 15 mg QD on day 1 (flexible 5-20 mg QD thereafter) given to verify assay sensitivity, or placebo.

The primary efficacy endpoint in each 3-week trial was the Young Mania Rating Scale (YMRS) total score change from baseline to day 21. The YMRS is an 11-item scale for assessing manic symptoms that has been widely validated.

Pooled data showed that the mean +- standard deviation (SD) changes from baseline to day 21 in YMRS total score were greater with asenapine (manic: -11.4 +- 11.3, n = 265, P < .0001; mixed: -10.4 +- 11.1, n = 107, P < .071) and olanzapine (manic: -14.3 +- 10.8, n = 269, P < .0001; mixed: -12.3 +- 8.2, n = 122, P < .003) than with placebo (manic: -6.1 +- 11.5, n = 131; mixed: -7.7 +- 10.2, n = 66).

Mean +- SD changes from baseline to day 21 in the Clinical Global Impression for Bipolar Disorder severity score were also greater with asenapine (manic: -1.2 +- 1.5, P = .0009; mixed: -1.4 +- 1.5, P = .009) and olanzapine (manic: -1.5 +- 1.3, []P[] < .0001; mixed: 1.3 +- 1.1, P = .003) than with placebo (manic: -0.8 +- 1.4; mixed: -0.8 +- 1.1).

Asenapine was generally well tolerated with a low incidence of extrapyramidal symptoms and a low incidence of clinically significant weight gain.

Funding for this study was provided by Schering-Plough and Pfizer, Inc.

[Presentation title: Asenapine Efficacy in Patient Subpopulations Experiencing Manic or Mixed Episodes of Bipolar Disorder: A Pooled Analysis. Abstract P-42-014]