The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies

Timothy Peters-Strickland,1 Ross A Baker,2 Pedro Such,3 Peter Zhang,4 Jessica J Madera21Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc.,...

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Autores principales:	Peters-Strickland T, Baker RA, Such P, Zhang P, Madera JJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	aripiprazole long-acting injectable antipsychotics schizophrenia patient function psychosocial function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/4b2fc0dc0ff246e390db26409089565d
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spelling	oai:doaj.org-article:4b2fc0dc0ff246e390db26409089565d2021-12-02T09:34:29ZThe effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies1178-2021https://doaj.org/article/4b2fc0dc0ff246e390db26409089565d2019-06-01T00:00:00Zhttps://www.dovepress.com/the-effect-of-aripiprazole-once-monthly-on-personal-and-social-functio-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Timothy Peters-Strickland,1 Ross A Baker,2 Pedro Such,3 Peter Zhang,4 Jessica J Madera21Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 3Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USAObjective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®,) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.Methods: Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).Results: In Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; P=0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; P=0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7–10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.Conclusion: AOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophrenia, patient function, psychosocial functionPeters-Strickland TBaker RASuch PZhang PMadera JJDove Medical Pressarticlearipiprazolelong-acting injectableantipsychoticsschizophreniapatient functionpsychosocial functionNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 1659-1669 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	aripiprazole long-acting injectable antipsychotics schizophrenia patient function psychosocial function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	aripiprazole long-acting injectable antipsychotics schizophrenia patient function psychosocial function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Peters-Strickland T Baker RA Such P Zhang P Madera JJ The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
description	Timothy Peters-Strickland,1 Ross A Baker,2 Pedro Such,3 Peter Zhang,4 Jessica J Madera21Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 3Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USAObjective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®,) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.Methods: Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).Results: In Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; P=0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; P=0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7–10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.Conclusion: AOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophrenia, patient function, psychosocial function
format	article
author	Peters-Strickland T Baker RA Such P Zhang P Madera JJ
author_facet	Peters-Strickland T Baker RA Such P Zhang P Madera JJ
author_sort	Peters-Strickland T
title	The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
title_short	The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
title_full	The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
title_fullStr	The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
title_full_unstemmed	The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
title_sort	effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/4b2fc0dc0ff246e390db26409089565d
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The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies

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