Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight

Robert L Findling,1 Willie Earley,2 Trisha Suppes,3,4 Mehul Patel,2 Xiao Wu,2 Cheng-Tao Chang,2 Roger S McIntyre5 1Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA; 2Allergan, Madison, NJ, USA; 3VA Palo Alto Health Care System, Palo Alto, CA, USA; 4Department of Psychi...

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Autores principales:	Findling RL, Earley W, Suppes T, Patel M, Wu X, Chang CT, McIntyre RS
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	asenapine child adolescent bipolar disorder atypical antipsychotic second-generation antipsychotic Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/3b27295387124c27b8444ba86caf3af8
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spelling	oai:doaj.org-article:3b27295387124c27b8444ba86caf3af82021-12-02T02:10:54ZPost hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight1178-2021https://doaj.org/article/3b27295387124c27b8444ba86caf3af82018-08-01T00:00:00Zhttps://www.dovepress.com/post-hoc-analyses-of-asenapine-treatment-in-pediatric-patients-with-bi-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Robert L Findling,1 Willie Earley,2 Trisha Suppes,3,4 Mehul Patel,2 Xiao Wu,2 Cheng-Tao Chang,2 Roger S McIntyre5 1Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA; 2Allergan, Madison, NJ, USA; 3VA Palo Alto Health Care System, Palo Alto, CA, USA; 4Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; 5Toronto Western Research Institute, Toronto, ON, Canada Background: Patient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10–17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). Patients and methods: Data were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10–17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (Diagnostic and Statistical Manual of Mental Disorders, fourth edition – defined mixed/manic), number of lifetime episodes (<3, 3–5, >5), and baseline BMI tertile. Changes from baseline to day 21 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP) were assessed in asenapine subgroups vs placebo. Results: In patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI. Keywords: asenapine, child, adolescent, bipolar disorder, atypical antipsychotic, second-generation antipsychoticFindling RLEarley WSuppes TPatel MWu XChang CTMcIntyre RSDove Medical Pressarticleasenapinechildadolescentbipolar disorderatypical antipsychoticsecond-generation antipsychoticNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 14, Pp 1941-1952 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	asenapine child adolescent bipolar disorder atypical antipsychotic second-generation antipsychotic Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	asenapine child adolescent bipolar disorder atypical antipsychotic second-generation antipsychotic Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Findling RL Earley W Suppes T Patel M Wu X Chang CT McIntyre RS Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
description	Robert L Findling,1 Willie Earley,2 Trisha Suppes,3,4 Mehul Patel,2 Xiao Wu,2 Cheng-Tao Chang,2 Roger S McIntyre5 1Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA; 2Allergan, Madison, NJ, USA; 3VA Palo Alto Health Care System, Palo Alto, CA, USA; 4Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; 5Toronto Western Research Institute, Toronto, ON, Canada Background: Patient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10–17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). Patients and methods: Data were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10–17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (Diagnostic and Statistical Manual of Mental Disorders, fourth edition – defined mixed/manic), number of lifetime episodes (<3, 3–5, >5), and baseline BMI tertile. Changes from baseline to day 21 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP) were assessed in asenapine subgroups vs placebo. Results: In patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI. Keywords: asenapine, child, adolescent, bipolar disorder, atypical antipsychotic, second-generation antipsychotic
format	article
author	Findling RL Earley W Suppes T Patel M Wu X Chang CT McIntyre RS
author_facet	Findling RL Earley W Suppes T Patel M Wu X Chang CT McIntyre RS
author_sort	Findling RL
title	Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
title_short	Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
title_full	Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
title_fullStr	Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
title_full_unstemmed	Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
title_sort	post hoc analyses of asenapine treatment in pediatric patients with bipolar i disorder: efficacy related to mixed or manic episode, stage of illness, and body weight
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/3b27295387124c27b8444ba86caf3af8
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Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight

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