Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder

Leslie Citrome,1 Ronald Landbloom,2 Cheng-Tao Chang,3 Willie Earley4 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Department of Neuroscience, Merck, Whitehouse Station, NJ, USA; 3Biostatistics, Allergan, Jersey City, NJ, USA; 4Clinical Development...

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Autores principales:	Citrome L, Landbloom R, Chang C, Earley W
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Asenapine hostility bipolar disorder agitation mania aggression Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/4c5d709eacdf41b08de83accf424de84
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spelling	oai:doaj.org-article:4c5d709eacdf41b08de83accf424de842021-12-02T02:08:48ZEffects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder1178-2021https://doaj.org/article/4c5d709eacdf41b08de83accf424de842017-12-01T00:00:00Zhttps://www.dovepress.com/effects-of-asenapine-on-agitation-and-hostility-in-adults-with-acute-m-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Leslie Citrome,1 Ronald Landbloom,2 Cheng-Tao Chang,3 Willie Earley4 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Department of Neuroscience, Merck, Whitehouse Station, NJ, USA; 3Biostatistics, Allergan, Jersey City, NJ, USA; 4Clinical Development, Allergan, Jersey City, NJ, USA Background: Bipolar disorder is associated with an increased risk of aggression. However, effective management of hostility and/or agitation symptoms may prevent patients from becoming violent. This analysis investigated the efficacy of the antipsychotic asenapine on hostility and agitation in patients with bipolar I disorder.Methods: Data were pooled from three randomized, double-blind, placebo-controlled, Phase III trials of asenapine in adults with manic or mixed episodes of bipolar I disorder (NCT00159744, NCT00159796, and NCT00764478). Post hoc analyses assessed the changes from baseline to day 21 on the Young Mania Rating Scale (YMRS) and the Positive and Negative Syndrome Scale (PANSS) hostility-related item scores in asenapine- or placebo-treated patients with at least minimal or mild symptom severity and on the PANSS-excited component (PANSS-EC) total score in agitated patients. Changes were adjusted for improvements in overall mania symptoms to investigate direct effects on hostility.Results: Significantly greater changes in favor of asenapine versus placebo were observed in YMRS hostility-related item scores (irritability: least squares mean difference [95% confidence interval] =–0.5 [–0.87, –0.22], P=0.001; disruptive–aggressive behavior: –0.7 [–0.99, –0.37], P<0.0001), PANSS hostility item score (–0.2 [–0.44, –0.04]; P=0.0181), and PANSS-EC total score (–1.4 [–2.4, –0.4]; P=0.0055). Changes in the YMRS disruptive–aggressive behavior score and the sum of the hostility-related items remained significant after adjusting for improvements in other YMRS item scores.Conclusion: Asenapine significantly reduced hostility and agitation in patients with bipolar I disorder; improvement was at least partially independent of overall improvement on mania symptoms. Keywords: asenapine, hostility, bipolar disorder, agitation, mania, aggressionCitrome LLandbloom RChang CEarley WDove Medical PressarticleAsenapinehostilitybipolar disorderagitationmaniaaggressionNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2955-2963 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Asenapine hostility bipolar disorder agitation mania aggression Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Asenapine hostility bipolar disorder agitation mania aggression Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Citrome L Landbloom R Chang C Earley W Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
description	Leslie Citrome,1 Ronald Landbloom,2 Cheng-Tao Chang,3 Willie Earley4 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Department of Neuroscience, Merck, Whitehouse Station, NJ, USA; 3Biostatistics, Allergan, Jersey City, NJ, USA; 4Clinical Development, Allergan, Jersey City, NJ, USA Background: Bipolar disorder is associated with an increased risk of aggression. However, effective management of hostility and/or agitation symptoms may prevent patients from becoming violent. This analysis investigated the efficacy of the antipsychotic asenapine on hostility and agitation in patients with bipolar I disorder.Methods: Data were pooled from three randomized, double-blind, placebo-controlled, Phase III trials of asenapine in adults with manic or mixed episodes of bipolar I disorder (NCT00159744, NCT00159796, and NCT00764478). Post hoc analyses assessed the changes from baseline to day 21 on the Young Mania Rating Scale (YMRS) and the Positive and Negative Syndrome Scale (PANSS) hostility-related item scores in asenapine- or placebo-treated patients with at least minimal or mild symptom severity and on the PANSS-excited component (PANSS-EC) total score in agitated patients. Changes were adjusted for improvements in overall mania symptoms to investigate direct effects on hostility.Results: Significantly greater changes in favor of asenapine versus placebo were observed in YMRS hostility-related item scores (irritability: least squares mean difference [95% confidence interval] =–0.5 [–0.87, –0.22], P=0.001; disruptive–aggressive behavior: –0.7 [–0.99, –0.37], P<0.0001), PANSS hostility item score (–0.2 [–0.44, –0.04]; P=0.0181), and PANSS-EC total score (–1.4 [–2.4, –0.4]; P=0.0055). Changes in the YMRS disruptive–aggressive behavior score and the sum of the hostility-related items remained significant after adjusting for improvements in other YMRS item scores.Conclusion: Asenapine significantly reduced hostility and agitation in patients with bipolar I disorder; improvement was at least partially independent of overall improvement on mania symptoms. Keywords: asenapine, hostility, bipolar disorder, agitation, mania, aggression
format	article
author	Citrome L Landbloom R Chang C Earley W
author_facet	Citrome L Landbloom R Chang C Earley W
author_sort	Citrome L
title	Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
title_short	Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
title_full	Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
title_fullStr	Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
title_full_unstemmed	Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder
title_sort	effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar i disorder
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/4c5d709eacdf41b08de83accf424de84
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Effects of asenapine on agitation and hostility in adults with acute manic or mixed episodes associated with bipolar I disorder

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