Lurasidone for the Treatment of Irritability Associated with Autistic Disorder

The aim of this study was to evaluate the short-term efficacy and safety of lurasidone in treating irritability associated with autistic disorder. In this multicenter trial, outpatients age 6–17 years who met DSM-IV-TR criteria for autistic disorder, and who demonstrated irritability, agitation, and...

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Main Authors:	Loebel, Antony, Brams, Matthew, Goldman, Robert S., Silva, Robert, Hernandez, David, Deng, Ling, Mankoski, Raymond, Findling, Robert L.
Format:	Online
Language:	English
Published:	Springer US 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4786592/

id	pubmed-4786592
recordtype	oai_dc
spelling	pubmed-47865922016-04-09 Lurasidone for the Treatment of Irritability Associated with Autistic Disorder Loebel, Antony Brams, Matthew Goldman, Robert S. Silva, Robert Hernandez, David Deng, Ling Mankoski, Raymond Findling, Robert L. Original Paper The aim of this study was to evaluate the short-term efficacy and safety of lurasidone in treating irritability associated with autistic disorder. In this multicenter trial, outpatients age 6–17 years who met DSM-IV-TR criteria for autistic disorder, and who demonstrated irritability, agitation, and/or self-injurious behaviors were randomized to 6 weeks of double-blind treatment with lurasidone 20 mg/day (N = 50), 60 mg/day (N = 49), or placebo (N = 51). Efficacy measures included the Aberrant Behavior Checklist Irritability subscale (ABC-I, the primary endpoint) and the Clinical Global Impressions, Improvement (CGI-I) scale, and were analyzed using a likelihood-based mixed model for repeated measures. Least squares (LS) mean (standard error [SE]) improvement from baseline to Week 6 in the ABC-I was not significantly different for lurasidone 20 mg/day (−8.8 [1.5]) and lurasidone 60 mg/day (−9.4 [1.4]) versus placebo (−7.5 [1.5]; p = 0.55 and 0.36, respectively). CGI-I scores showed significantly greater LS mean [SE] improvement at Week 6 for lurasidone 20 mg/day versus placebo (2.8 [0.2] vs. 3.4 [0.2]; p = 0.035) but not for lurasidone 60 mg/day (3.1 [0.2]; p = 0.27). Discontinuation rates due to adverse events were: lurasidone 20 mg/day, 4.1 %; 60 mg/day, 3.9 %; and placebo, 8.2 %. Adverse events with an incidence ≥10 % (lurasidone combined, placebo) included vomiting (18.0, 4.1 %) and somnolence (12.0, 4.1 %). Modest changes were observed in weight and selected metabolic parameters. In this study, once-daily, fixed doses of 20 and 60 mg/day of lurasidone were not demonstrated to be efficacious compared to placebo for the short-term treatment of children and adolescents with moderate-to-severe irritability associated with autistic disorder. Springer US 2015-12-11 2016 /pmc/articles/PMC4786592/ /pubmed/26659550 http://dx.doi.org/10.1007/s10803-015-2628-x Text en © The Author(s) 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Loebel, Antony Brams, Matthew Goldman, Robert S. Silva, Robert Hernandez, David Deng, Ling Mankoski, Raymond Findling, Robert L.
spellingShingle	Loebel, Antony Brams, Matthew Goldman, Robert S. Silva, Robert Hernandez, David Deng, Ling Mankoski, Raymond Findling, Robert L. Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
author_facet	Loebel, Antony Brams, Matthew Goldman, Robert S. Silva, Robert Hernandez, David Deng, Ling Mankoski, Raymond Findling, Robert L.
author_sort	Loebel, Antony
title	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
title_short	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
title_full	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
title_fullStr	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
title_full_unstemmed	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
title_sort	lurasidone for the treatment of irritability associated with autistic disorder
description	The aim of this study was to evaluate the short-term efficacy and safety of lurasidone in treating irritability associated with autistic disorder. In this multicenter trial, outpatients age 6–17 years who met DSM-IV-TR criteria for autistic disorder, and who demonstrated irritability, agitation, and/or self-injurious behaviors were randomized to 6 weeks of double-blind treatment with lurasidone 20 mg/day (N = 50), 60 mg/day (N = 49), or placebo (N = 51). Efficacy measures included the Aberrant Behavior Checklist Irritability subscale (ABC-I, the primary endpoint) and the Clinical Global Impressions, Improvement (CGI-I) scale, and were analyzed using a likelihood-based mixed model for repeated measures. Least squares (LS) mean (standard error [SE]) improvement from baseline to Week 6 in the ABC-I was not significantly different for lurasidone 20 mg/day (−8.8 [1.5]) and lurasidone 60 mg/day (−9.4 [1.4]) versus placebo (−7.5 [1.5]; p = 0.55 and 0.36, respectively). CGI-I scores showed significantly greater LS mean [SE] improvement at Week 6 for lurasidone 20 mg/day versus placebo (2.8 [0.2] vs. 3.4 [0.2]; p = 0.035) but not for lurasidone 60 mg/day (3.1 [0.2]; p = 0.27). Discontinuation rates due to adverse events were: lurasidone 20 mg/day, 4.1 %; 60 mg/day, 3.9 %; and placebo, 8.2 %. Adverse events with an incidence ≥10 % (lurasidone combined, placebo) included vomiting (18.0, 4.1 %) and somnolence (12.0, 4.1 %). Modest changes were observed in weight and selected metabolic parameters. In this study, once-daily, fixed doses of 20 and 60 mg/day of lurasidone were not demonstrated to be efficacious compared to placebo for the short-term treatment of children and adolescents with moderate-to-severe irritability associated with autistic disorder.
publisher	Springer US
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4786592/
_version_	1613550326003007488

Lurasidone for the Treatment of Irritability Associated with Autistic Disorder

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