Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto
Autor(a) principal: | |
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Data de Publicação: | 2007 |
Outros Autores: | , , , , , , , , , , , , , |
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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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 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
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 |
language |
por |
dc.relation.none.fl_str_mv |
Jornal Brasileiro de Psiquiatria |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
17-22 application/pdf |
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 |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
instname_str |
Universidade Federal de São Paulo (UNIFESP) |
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UNIFESP |
institution |
UNIFESP |
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Repositório Institucional da UNIFESP |
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Repositório Institucional da UNIFESP |
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Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
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biblioteca.csp@unifesp.br |
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1814268359036895232 |