An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients

Chawanun Charnsil,1 Salinee Vongpanich21Department of Psychiatry, Chiang Mai University, Chiang Mai, Thailand; 2Medical Affairs Department, Janssen-Cilag, Bangkok, ThailandBackground: Previous studies with extended-release (ER) paliperidone have reported an effective outcome in terms of personal and...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Charnsil C, Vongpanich S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/7b276e8a2e404f87b4eff4ad30b12e26
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:7b276e8a2e404f87b4eff4ad30b12e26
record_format	dspace
spelling	oai:doaj.org-article:7b276e8a2e404f87b4eff4ad30b12e262021-12-02T00:23:10ZAn open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients1176-63281178-2021https://doaj.org/article/7b276e8a2e404f87b4eff4ad30b12e262013-08-01T00:00:00Zhttp://www.dovepress.com/an-open-label-prospective-study-to-evaluate-social-function-and-overal-a14103https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Chawanun Charnsil,1 Salinee Vongpanich21Department of Psychiatry, Chiang Mai University, Chiang Mai, Thailand; 2Medical Affairs Department, Janssen-Cilag, Bangkok, ThailandBackground: Previous studies with extended-release (ER) paliperidone have reported an effective outcome in terms of personal and social functioning improvement and also reported schizophrenia symptom improvement. The main objectives of this study were to further investigate improvements in symptom control and social functioning of paliperidone ER and acknowledge the safety profile of paliperidone ER in Thai patients with schizophrenia.Patients and methods: Patients with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders criteria were allowed flexible 3–12 mg/day dosing during the 10-week study duration. Patients were interviewed and assessed in social functioning using the Personal and Social Performance (PSP) scale. Patients were also rated on overall severity of illness using the Clinical and Global Impressions – Severity (CGI-S) scale.Results: In total, 40 patients were enrolled, 80% of enrolled patients (n = 32) completed the 10-week study period. Thirty-eight eligible patients were included in the intention-to-treat analysis set (male 39.5%, female 60.5%). One patient was lost to follow-up without postbaseline-efficacy measurements. Another patient was terminated early due to a change in diagnosis during the trial. Statistically significant improvements from baseline in PSP total score were observed at all time points. Clinically relevant improvement in PSP (increase of at least one 10-point category) was observed in 47.40% of patients at end point. Improvement in CGI-S was observed at end point (P < 0.001). The mean reduction ± standard deviation at end point in CGI-S was 0.8 ± 1.04 (95% confidence interval 0.48–1.16). The most commonly reported adverse events (≥5% of patients) were daytime drowsiness (15%) and headache (15%). Three subjects (7.5%) discontinued due to adverse events.Conclusion: This study suggests that paliperidone ER is well tolerated in Thai patients with schizophrenia. Paliperidone ER showed improvement in schizophrenic symptom control and social functioning.Keywords: schizophrenia, social function, paliperidoneCharnsil CVongpanich SDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2013, Iss default, Pp 1223-1230 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Charnsil C Vongpanich S An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
description	Chawanun Charnsil,1 Salinee Vongpanich21Department of Psychiatry, Chiang Mai University, Chiang Mai, Thailand; 2Medical Affairs Department, Janssen-Cilag, Bangkok, ThailandBackground: Previous studies with extended-release (ER) paliperidone have reported an effective outcome in terms of personal and social functioning improvement and also reported schizophrenia symptom improvement. The main objectives of this study were to further investigate improvements in symptom control and social functioning of paliperidone ER and acknowledge the safety profile of paliperidone ER in Thai patients with schizophrenia.Patients and methods: Patients with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders criteria were allowed flexible 3–12 mg/day dosing during the 10-week study duration. Patients were interviewed and assessed in social functioning using the Personal and Social Performance (PSP) scale. Patients were also rated on overall severity of illness using the Clinical and Global Impressions – Severity (CGI-S) scale.Results: In total, 40 patients were enrolled, 80% of enrolled patients (n = 32) completed the 10-week study period. Thirty-eight eligible patients were included in the intention-to-treat analysis set (male 39.5%, female 60.5%). One patient was lost to follow-up without postbaseline-efficacy measurements. Another patient was terminated early due to a change in diagnosis during the trial. Statistically significant improvements from baseline in PSP total score were observed at all time points. Clinically relevant improvement in PSP (increase of at least one 10-point category) was observed in 47.40% of patients at end point. Improvement in CGI-S was observed at end point (P < 0.001). The mean reduction ± standard deviation at end point in CGI-S was 0.8 ± 1.04 (95% confidence interval 0.48–1.16). The most commonly reported adverse events (≥5% of patients) were daytime drowsiness (15%) and headache (15%). Three subjects (7.5%) discontinued due to adverse events.Conclusion: This study suggests that paliperidone ER is well tolerated in Thai patients with schizophrenia. Paliperidone ER showed improvement in schizophrenic symptom control and social functioning.Keywords: schizophrenia, social function, paliperidone
format	article
author	Charnsil C Vongpanich S
author_facet	Charnsil C Vongpanich S
author_sort	Charnsil C
title	An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
title_short	An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
title_full	An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
title_fullStr	An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
title_full_unstemmed	An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients
title_sort	open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in thai schizophrenia patients
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/7b276e8a2e404f87b4eff4ad30b12e26
work_keys_str_mv	AT charnsilc anopenlabelprospectivestudytoevaluatesocialfunctionandoverallimprovementofextendedreleasepaliperidonetreatmentinthaischizophreniapatients AT vongpanichs anopenlabelprospectivestudytoevaluatesocialfunctionandoverallimprovementofextendedreleasepaliperidonetreatmentinthaischizophreniapatients AT charnsilc openlabelprospectivestudytoevaluatesocialfunctionandoverallimprovementofextendedreleasepaliperidonetreatmentinthaischizophreniapatients AT vongpanichs openlabelprospectivestudytoevaluatesocialfunctionandoverallimprovementofextendedreleasepaliperidonetreatmentinthaischizophreniapatients
_version_	1718403746197667840

An open-label, prospective study to evaluate social function and overall improvement of extended-release paliperidone treatment in Thai schizophrenia patients

Ejemplares similares