Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto

Detalhes bibliográficos
Autor(a) principal: Porto, Jose Alberto Del [UNIFESP]
Data de Publicação: 2007
Outros Autores: Mello, Andréa Feijó de [UNIFESP], Kerr-Correa, Florence, Santos Junior, Andrés dos, Moreno, Ricardo Alberto, Santos, Carlos Henrique Rodrigues dos, Chaves, Aline Valente, Versiani, Marcio, Nardi, Antônio Egídio, Oliveira, Irismar Reis de, Ribeiro, Mônica Gonçalves, Kapczinski, Flávio, Gazalle, Fernando, Frey, Benício, Tamai, Sérgio
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://dx.doi.org/10.1590/S0047-20852007000100006
http://repositorio.unifesp.br/handle/11600/3454
Resumo: OBJECTIVE: This research studied the efficacy and tolerability of fluvoxamine in the treatment of major depressive disorder (MDD), during 6 weeks, in an open trial, without placebo or active comparator. A secondary objective was the evaluation of the effects of fluvoxamine on the sleep of the pacients. METHODS: 104 patients were inicially included, with the diagnosis of MDD in accordance to the criteria of the Diagnostic and Statistical Manual for Mental Disorders, 4th edition (DSM-IV). Patients should have scores > 17 in the Hamilton Depression Scale for Depression 17 itens (HAM-D 17). The efficacy of fluvoxamine was studied through the HAM-D 17 and CGI (Clinical Global Impression). The analysis of the HAM-D 17 itens 4, 5, and 6 was used for the evaluation of the quality of sleep of the patients. Security and tolerability of fluvoxamine was assessed throughout the six weeks, being registered any adverse event. Fluvoxamine was inicially administered at the doses of 50 or 100 mg/day; the doses could be progressively increased until 300 mg/day. RESULTS: From the 104 included patients, 81 (78%) concluded the study. Sixty nine percent (69%) of the patients obtained favorable response (defined as 50% improvement in the HAM-D 17) and the remission rate (HAM-D 17 < 7) was 52%. The specific analysis of CGI showed significant improvement (p < 0.001) comparing to the baseline scores. The speficic analysis of the sleep itens of the HAM-D 17 showed significant improvement from the 2nd week; the improvement was sustained until the end of the 6 weeks study. The adverse events were those expected for the serotonin selective reuptake inhibitors (SSRI), predominantly gastrointestinal complaints, transitory and of low intensity in most of the cases. CONCLUSION: This study confirms the efficacy and tolerability of fluvoxamine in the treatment of MDD, and also its efficacy in the treatment of sleep disturbs among depressed patients. The profile of adverse events were those expected for SSRI. It should be emphasized that few patients reported sexual disfunction (2.5% of the patients).
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spelling Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico abertoFluvoxamine in the treatment of major depressive disorder: an open multicentric studyOBJECTIVE: This research studied the efficacy and tolerability of fluvoxamine in the treatment of major depressive disorder (MDD), during 6 weeks, in an open trial, without placebo or active comparator. A secondary objective was the evaluation of the effects of fluvoxamine on the sleep of the pacients. METHODS: 104 patients were inicially included, with the diagnosis of MDD in accordance to the criteria of the Diagnostic and Statistical Manual for Mental Disorders, 4th edition (DSM-IV). Patients should have scores > 17 in the Hamilton Depression Scale for Depression 17 itens (HAM-D 17). The efficacy of fluvoxamine was studied through the HAM-D 17 and CGI (Clinical Global Impression). The analysis of the HAM-D 17 itens 4, 5, and 6 was used for the evaluation of the quality of sleep of the patients. Security and tolerability of fluvoxamine was assessed throughout the six weeks, being registered any adverse event. Fluvoxamine was inicially administered at the doses of 50 or 100 mg/day; the doses could be progressively increased until 300 mg/day. RESULTS: From the 104 included patients, 81 (78%) concluded the study. Sixty nine percent (69%) of the patients obtained favorable response (defined as 50% improvement in the HAM-D 17) and the remission rate (HAM-D 17 < 7) was 52%. The specific analysis of CGI showed significant improvement (p < 0.001) comparing to the baseline scores. The speficic analysis of the sleep itens of the HAM-D 17 showed significant improvement from the 2nd week; the improvement was sustained until the end of the 6 weeks study. The adverse events were those expected for the serotonin selective reuptake inhibitors (SSRI), predominantly gastrointestinal complaints, transitory and of low intensity in most of the cases. CONCLUSION: This study confirms the efficacy and tolerability of fluvoxamine in the treatment of MDD, and also its efficacy in the treatment of sleep disturbs among depressed patients. The profile of adverse events were those expected for SSRI. It should be emphasized that few patients reported sexual disfunction (2.5% of the patients).OBJETIVO: Este trabalho estudou a eficácia e a tolerabilidade da fluvoxamina no tratamento, de forma aberta, sem comparação com placebo ou outros agentes, por 6 semanas, de pacientes com o diagnóstico de transtorno depressivo maior (TDM). Constitui-se em objetivo secundário do estudo avaliar os efeitos da fluvoxamina sobre o sono dos pacientes. MÉTODOS: Foram incluídos 104 pacientes, maiores de 18 anos, com o diagnóstico de TDM, de acordo com os critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais, 4ª edição (DSM-IV), e com escores, na Escala de Hamilton para Depressão, versão de 17 itens (HAM-D 17), de 17 pontos ou mais. Avaliou-se a eficácia da fluvoxamina por meio das Escalas HAM-D 17 e da CGI (Impressão Clínica Global). A análise dos itens 4, 5 e 6 da HAM-D 17 foi utilizada para a avaliação do sono dos pacientes. Avaliaram-se a segurança e a tolerabilidade da fluvoxamina ao longo das 6 semanas, registrando-se quaisquer eventos adversos. A fluvoxamina foi inicialmente ministrada em doses de 50 ou 100 mg/dia, podendo haver aumentos progressivos até 300 mg/dia. RESULTADOS: Dos 104 pacientes incluídos, 81 (78%) concluíram o estudo. Obtiveram resposta favorável (diminuição de 50% ou mais na HAM-D 17) 69% dos pacientes, e a taxa de remissão (HAM-D 17 < 7) foi de 52%. A análise da CGI indicou ter havido melhora significante (p < 0,001) em relação aos escores de base. A análise específica dos itens relativos ao sono, na HAM-D 17, revelou melhora significativa já na segunda visita, mantendo-se ao longo das 6 semanas. Os eventos adversos foram os esperados para inibidores seletivos de recaptação da serotonina, predominando as queixas gastrointestinais, em sua maioria transitórias e de pequena intensidade. CONCLUSÃO: O estudo vem confirmar a eficácia e a tolerabilidade da fluvoxamina no tratamento do transtorno depressivo maior, assim como sua eficácia no tratamento das alterações do sono encontradas nos pacientes deprimidos. O perfil de eventos adversos foi o esperado para os ISRS, ressaltando-se o fato de que poucos pacientes relataram disfunção sexual (2,5% dos pacientes).Universidade Federal de São Paulo (UNIFESP)Universidade Estadual Paulista Faculdade de Medicina de Botucatu Hospital das ClínicasHospital do Servidor Público Estadual de São PauloUniversidade de São Paulo Faculdade de Medicina Hospital das ClínicasUniversidade Federal do Rio de Janeiro Instituto de PsiquiatriaCasa de Saúde Ana NeryUniversidade Federal do Rio Grande do Sul Faculdade de Medicina Hospital das ClínicasSanta Casa de São Paulo Faculdade de Ciências MédicasUNIFESPSciELOInstituto de Psiquiatria da Universidade Federal do Rio de JaneiroUniversidade Federal de São Paulo (UNIFESP)Universidade Estadual Paulista (UNESP)Hospital do Servidor Público Estadual de São PauloUniversidade de São Paulo (USP)Universidade Federal do Rio de Janeiro Instituto de PsiquiatriaCasa de Saúde Ana NeryUniversidade Federal do Rio Grande do Sul Faculdade de Medicina Hospital das ClínicasSanta Casa de São Paulo Faculdade de Ciências MédicasPorto, Jose Alberto Del [UNIFESP]Mello, Andréa Feijó de [UNIFESP]Kerr-Correa, FlorenceSantos Junior, Andrés dosMoreno, Ricardo AlbertoSantos, Carlos Henrique Rodrigues dosChaves, Aline ValenteVersiani, MarcioNardi, Antônio EgídioOliveira, Irismar Reis deRibeiro, Mônica GonçalvesKapczinski, FlávioGazalle, FernandoFrey, BenícioTamai, Sérgio2015-06-14T13:36:38Z2015-06-14T13:36:38Z2007-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion17-22application/pdfhttp://dx.doi.org/10.1590/S0047-20852007000100006Jornal Brasileiro de Psiquiatria. Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, v. 56, n. 1, p. 17-22, 2007.10.1590/S0047-20852007000100006S0047-20852007000100006.pdf0047-2085S0047-20852007000100006http://repositorio.unifesp.br/handle/11600/3454porJornal Brasileiro de Psiquiatriainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-08-05T20:01:10Zoai:repositorio.unifesp.br/:11600/3454Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-08-05T20:01:10Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
Fluvoxamine in the treatment of major depressive disorder: an open multicentric study
title Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
spellingShingle Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
Porto, Jose Alberto Del [UNIFESP]
title_short Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
title_full Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
title_fullStr Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
title_full_unstemmed Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
title_sort Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
author Porto, Jose Alberto Del [UNIFESP]
author_facet Porto, Jose Alberto Del [UNIFESP]
Mello, Andréa Feijó de [UNIFESP]
Kerr-Correa, Florence
Santos Junior, Andrés dos
Moreno, Ricardo Alberto
Santos, Carlos Henrique Rodrigues dos
Chaves, Aline Valente
Versiani, Marcio
Nardi, Antônio Egídio
Oliveira, Irismar Reis de
Ribeiro, Mônica Gonçalves
Kapczinski, Flávio
Gazalle, Fernando
Frey, Benício
Tamai, Sérgio
author_role author
author2 Mello, Andréa Feijó de [UNIFESP]
Kerr-Correa, Florence
Santos Junior, Andrés dos
Moreno, Ricardo Alberto
Santos, Carlos Henrique Rodrigues dos
Chaves, Aline Valente
Versiani, Marcio
Nardi, Antônio Egídio
Oliveira, Irismar Reis de
Ribeiro, Mônica Gonçalves
Kapczinski, Flávio
Gazalle, Fernando
Frey, Benício
Tamai, Sérgio
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
Universidade Estadual Paulista (UNESP)
Hospital do Servidor Público Estadual de São Paulo
Universidade de São Paulo (USP)
Universidade Federal do Rio de Janeiro Instituto de Psiquiatria
Casa de Saúde Ana Nery
Universidade Federal do Rio Grande do Sul Faculdade de Medicina Hospital das Clínicas
Santa Casa de São Paulo Faculdade de Ciências Médicas
dc.contributor.author.fl_str_mv Porto, Jose Alberto Del [UNIFESP]
Mello, Andréa Feijó de [UNIFESP]
Kerr-Correa, Florence
Santos Junior, Andrés dos
Moreno, Ricardo Alberto
Santos, Carlos Henrique Rodrigues dos
Chaves, Aline Valente
Versiani, Marcio
Nardi, Antônio Egídio
Oliveira, Irismar Reis de
Ribeiro, Mônica Gonçalves
Kapczinski, Flávio
Gazalle, Fernando
Frey, Benício
Tamai, Sérgio
description OBJECTIVE: This research studied the efficacy and tolerability of fluvoxamine in the treatment of major depressive disorder (MDD), during 6 weeks, in an open trial, without placebo or active comparator. A secondary objective was the evaluation of the effects of fluvoxamine on the sleep of the pacients. METHODS: 104 patients were inicially included, with the diagnosis of MDD in accordance to the criteria of the Diagnostic and Statistical Manual for Mental Disorders, 4th edition (DSM-IV). Patients should have scores > 17 in the Hamilton Depression Scale for Depression 17 itens (HAM-D 17). The efficacy of fluvoxamine was studied through the HAM-D 17 and CGI (Clinical Global Impression). The analysis of the HAM-D 17 itens 4, 5, and 6 was used for the evaluation of the quality of sleep of the patients. Security and tolerability of fluvoxamine was assessed throughout the six weeks, being registered any adverse event. Fluvoxamine was inicially administered at the doses of 50 or 100 mg/day; the doses could be progressively increased until 300 mg/day. RESULTS: From the 104 included patients, 81 (78%) concluded the study. Sixty nine percent (69%) of the patients obtained favorable response (defined as 50% improvement in the HAM-D 17) and the remission rate (HAM-D 17 < 7) was 52%. The specific analysis of CGI showed significant improvement (p < 0.001) comparing to the baseline scores. The speficic analysis of the sleep itens of the HAM-D 17 showed significant improvement from the 2nd week; the improvement was sustained until the end of the 6 weeks study. The adverse events were those expected for the serotonin selective reuptake inhibitors (SSRI), predominantly gastrointestinal complaints, transitory and of low intensity in most of the cases. CONCLUSION: This study confirms the efficacy and tolerability of fluvoxamine in the treatment of MDD, and also its efficacy in the treatment of sleep disturbs among depressed patients. The profile of adverse events were those expected for SSRI. It should be emphasized that few patients reported sexual disfunction (2.5% of the patients).
publishDate 2007
dc.date.none.fl_str_mv 2007-01-01
2015-06-14T13:36:38Z
2015-06-14T13:36:38Z
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dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1590/S0047-20852007000100006
Jornal Brasileiro de Psiquiatria. Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, v. 56, n. 1, p. 17-22, 2007.
10.1590/S0047-20852007000100006
S0047-20852007000100006.pdf
0047-2085
S0047-20852007000100006
http://repositorio.unifesp.br/handle/11600/3454
url http://dx.doi.org/10.1590/S0047-20852007000100006
http://repositorio.unifesp.br/handle/11600/3454
identifier_str_mv Jornal Brasileiro de Psiquiatria. Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, v. 56, n. 1, p. 17-22, 2007.
10.1590/S0047-20852007000100006
S0047-20852007000100006.pdf
0047-2085
S0047-20852007000100006
dc.language.iso.fl_str_mv por
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dc.relation.none.fl_str_mv Jornal Brasileiro de Psiquiatria
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dc.publisher.none.fl_str_mv Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
publisher.none.fl_str_mv Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
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