[article] 
inJournal of Autism and Developmental Disorders > 46-4 (April 2016) . - p.1153-1163

Titre :	Lurasidone for the Treatment of Irritability Associated with Autistic Disorder
Type de document :	Texte imprimé et/ou numérique
Auteurs :	Antony LOEBEL, Auteur ; Matthew BRAMS, Auteur ; Robert S. GOLDMAN, Auteur ; Robert SILVA, Auteur ; David HERNANDEZ, Auteur ; Ling DENG, Auteur ; Raymond MANKOSKI, Auteur ; Robert L. FINDLING, Auteur
Année de publication :	2016
Article en page(s) :	p.1153-1163
Langues :	Anglais (eng)
Mots-clés :	Autism  Irritability  Lurasidone  Atypical antipsychotic
Index. décimale :	PER Périodiques
Résumé :	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.
En ligne :	http://dx.doi.org/10.1007/s10803-015-2628-x
Permalink :	https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=284

[article] Lurasidone for the Treatment of Irritability Associated with Autistic Disorder [Texte imprimé et/ou numérique] / Antony LOEBEL, Auteur ; Matthew BRAMS, Auteur ; Robert S. GOLDMAN, Auteur ; Robert SILVA, Auteur ; David HERNANDEZ, Auteur ; Ling DENG, Auteur ; Raymond MANKOSKI, Auteur ; Robert L. FINDLING, Auteur . - 2016 . - p.1153-1163.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 46-4 (April 2016) . - p.1153-1163

Mots-clés :	Autism  Irritability  Lurasidone  Atypical antipsychotic
Index. décimale :	PER Périodiques
Résumé :	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.
En ligne :	http://dx.doi.org/10.1007/s10803-015-2628-x
Permalink :	https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=284