Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-bli...

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Autores principales:	Yahno NN, Fedotova AV
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Depression anxiety fluvoxamine neurological disease sleep cognitive function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/3a5f45784e604fa6bd570a5df88cc339
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spelling	oai:doaj.org-article:3a5f45784e604fa6bd570a5df88cc3392021-12-02T04:46:06ZPost-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study1178-2021https://doaj.org/article/3a5f45784e604fa6bd570a5df88cc3392017-11-01T00:00:00Zhttps://www.dovepress.com/post-marketing-observational-program-of-the-effectiveness-of-fluvoxami-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50–300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001) improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both). No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine, neurological disease, sleep, cognitive functionYahno NNFedotova AVDove Medical PressarticleDepressionanxietyfluvoxamineneurological diseasesleepcognitive functionNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2747-2756 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Depression anxiety fluvoxamine neurological disease sleep cognitive function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Depression anxiety fluvoxamine neurological disease sleep cognitive function Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Yahno NN Fedotova AV Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
description	Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50–300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001) improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both). No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine, neurological disease, sleep, cognitive function
format	article
author	Yahno NN Fedotova AV
author_facet	Yahno NN Fedotova AV
author_sort	Yahno NN
title	Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
title_short	Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
title_full	Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
title_fullStr	Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
title_full_unstemmed	Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study
title_sort	post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the friends study
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/3a5f45784e604fa6bd570a5df88cc339
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Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

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