Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study

Jean-Pierre Oli&eacute;1, David Gourion2, Agn&egrave;s Montagne3, Michel Rostin4, Marie-France Poirier11Service de Sant&eacute; Mentale et Th&eacute;rapeutique, Centre Hospitalier Sainte-Anne, Paris, France; 217 rue des Marronniers, 75016 Paris, France; 3Pierre Fabre...

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Autores principales:	Jean-Pierre Oli&eacute;, David Gourion, Agn&egrave;s Montagne, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2010
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/af4470274d6b4db1ababa06107fc2822
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spelling	oai:doaj.org-article:af4470274d6b4db1ababa06107fc28222021-12-02T01:10:03ZMilnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study1176-63281178-2021https://doaj.org/article/af4470274d6b4db1ababa06107fc28222010-03-01T00:00:00Zhttp://www.dovepress.com/milnacipran-and-venlafaxine-at-flexible-doses-up-to-200-mgday-in-the-o-a4118https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Jean-Pierre Oli&eacute;1, David Gourion2, Agn&egrave;s Montagne3, Michel Rostin4, Marie-France Poirier11Service de Sant&eacute; Mentale et Th&eacute;rapeutique, Centre Hospitalier Sainte-Anne, Paris, France; 217 rue des Marronniers, 75016 Paris, France; 3Pierre Fabre M&eacute;dicament, Lab&egrave;ge, France; 4Pierre Fabre M&eacute;dicament, Castres, FranceAbstract: The objective of this exploratory, multicenter, randomized, double-blind study, was to evaluate the efficacy and safety/tolerability of milnacipran and venlafaxine administered at flexible doses (100, 150 or 200 mg/day, bid administration) for 24 weeks (including 4 weeks up titration period) in the outpatient treatment of adults presenting with a moderate or severe episode of major depressive disorder (MDD) without high suicidal risk (MINI-DSM IV-TR). Of the 195 patients included, 134 (68.7%) completed the study. At baseline the two groups were similar, except there was a higher proportion of patients whose episode was severe-DSM IV in the milnacipran group (63.3% versus 54.0% in the venlafaxine group). The initial MADRS score (mean 31.0) decreased progressively during the study, and this decrease was in the two treatment groups (n = 177: 90 milnacipran; 87 venlafaxine) at week 24 (observed case/OC, mean change &ndash;23.1 milnacipran; &ndash;22.4 venlafaxine). The rate of MADRS response (reduction &ge; 50%) at week 8 and week 24-last observation carried forward/LOCF was similar in the two groups (week 8: 64.4% milnacipran; 65.5% venlafaxine; week 24: 70% milnacipran; 77% venlafaxine), as was the rate of MADRS remission (score &le; 10) (week 8: 42.2% milnacipran; 42.5% venlafaxine; week 24: 52.2% milnacipran; 62.1% venlafaxine). In both groups, the most common adverse events were: nausea, dizziness, headache, hyperhidrosis and, in males, genito-urinary problems. The overall safety/tolerability and efficacy profiles of milnacipran and venlafaxine administered at flexible dosages (up to 200 mg/day) were similar in the long term treatment of adults during episodes of MDD in an outpatient setting.Keywords: major depressive episode, adult, serotonin and norepinephrine reuptake inhibitors, milnacipran, venlafaxine Jean-Pierre Oli&eacute;David GourionAgn&egrave;s Montagneet alDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2010, Iss Issue 1, Pp 71-79 (2010)
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 Jean-Pierre Oli&eacute; David Gourion Agn&egrave;s Montagne et al Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
description	Jean-Pierre Oli&eacute;1, David Gourion2, Agn&egrave;s Montagne3, Michel Rostin4, Marie-France Poirier11Service de Sant&eacute; Mentale et Th&eacute;rapeutique, Centre Hospitalier Sainte-Anne, Paris, France; 217 rue des Marronniers, 75016 Paris, France; 3Pierre Fabre M&eacute;dicament, Lab&egrave;ge, France; 4Pierre Fabre M&eacute;dicament, Castres, FranceAbstract: The objective of this exploratory, multicenter, randomized, double-blind study, was to evaluate the efficacy and safety/tolerability of milnacipran and venlafaxine administered at flexible doses (100, 150 or 200 mg/day, bid administration) for 24 weeks (including 4 weeks up titration period) in the outpatient treatment of adults presenting with a moderate or severe episode of major depressive disorder (MDD) without high suicidal risk (MINI-DSM IV-TR). Of the 195 patients included, 134 (68.7%) completed the study. At baseline the two groups were similar, except there was a higher proportion of patients whose episode was severe-DSM IV in the milnacipran group (63.3% versus 54.0% in the venlafaxine group). The initial MADRS score (mean 31.0) decreased progressively during the study, and this decrease was in the two treatment groups (n = 177: 90 milnacipran; 87 venlafaxine) at week 24 (observed case/OC, mean change &ndash;23.1 milnacipran; &ndash;22.4 venlafaxine). The rate of MADRS response (reduction &ge; 50%) at week 8 and week 24-last observation carried forward/LOCF was similar in the two groups (week 8: 64.4% milnacipran; 65.5% venlafaxine; week 24: 70% milnacipran; 77% venlafaxine), as was the rate of MADRS remission (score &le; 10) (week 8: 42.2% milnacipran; 42.5% venlafaxine; week 24: 52.2% milnacipran; 62.1% venlafaxine). In both groups, the most common adverse events were: nausea, dizziness, headache, hyperhidrosis and, in males, genito-urinary problems. The overall safety/tolerability and efficacy profiles of milnacipran and venlafaxine administered at flexible dosages (up to 200 mg/day) were similar in the long term treatment of adults during episodes of MDD in an outpatient setting.Keywords: major depressive episode, adult, serotonin and norepinephrine reuptake inhibitors, milnacipran, venlafaxine
format	article
author	Jean-Pierre Oli&eacute; David Gourion Agn&egrave;s Montagne et al
author_facet	Jean-Pierre Oli&eacute; David Gourion Agn&egrave;s Montagne et al
author_sort	Jean-Pierre Oli&eacute;
title	Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
title_short	Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
title_full	Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
title_fullStr	Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
title_full_unstemmed	Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
title_sort	milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study
publisher	Dove Medical Press
publishDate	2010
url	https://doaj.org/article/af4470274d6b4db1ababa06107fc2822
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Milnacipran and venlafaxine at flexible doses (up to 200 mg/day) in the outpatient treatment of adults with moderate-to-severe major depressive disorder: a 24-week randomized, double-blind exploratory study

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