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.
abstract: 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 -23.1 milnacipran; -22.4 venlafaxine). The rate of MADRS response (reduction >/= 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 </= 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.
authors.affiliation: Service de Santé Mentale et Thérapeutique, Centre Hospitalier Sainte-Anne, Paris, France. jp.olie@ch-sainte-anne.fr
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Olié
authors.forename: David
authors.initials: D
authors.lastname: Gourion
authors.forename: Agnès
authors.initials: A
authors.lastname: Montagne
authors.forename: Michel
authors.initials: M
authors.lastname: Rostin
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Poirier
references.citation: Curr Med Res Opin. 2006 Sep;22(9):1825-37
references.pmid: 16968586
references.citation: Eur Arch Psychiatry Clin Neurosci. 2009 Apr;259(3):172-85
references.pmid: 19165525
references.citation: Int Clin Psychopharmacol. 1997 Jan;12(1):19-29
references.pmid: 9179630
references.citation: Clin Drug Investig. 2006;26(3):135-42
references.pmid: 17163244
references.citation: JAMA. 1996 Jul 24-31;276(4):293-9
references.pmid: 8656541
references.citation: CNS Spectr. 2005 Sep;10(9):732-47
references.pmid: 16142213
references.citation: Eur Neuropsychopharmacol. 1991 May;1(2):113-21
references.pmid: 1821700
references.citation: Int Clin Psychopharmacol. 1996 Mar;11 Suppl 1:13-7
references.pmid: 8732439
references.citation: Neuropsychiatr Dis Treat. 2007;3(5):699-702
references.pmid: 19300602
references.citation: Int Clin Psychopharmacol. 1997 Sep;12(5):269-81
references.pmid: 9466161
references.citation: Drugs. 1996 Nov;52(5):625-38
references.pmid: 9118813
references.citation: Encephale. 2009 Dec;35(6):595-604
references.pmid: 20004291
references.citation: Int Clin Psychopharmacol. 2007 Nov;22(6):323-9
references.pmid: 17917550
references.citation: Br J Psychiatry. 1970 Oct;117(539):437-8
references.pmid: 5481206
references.citation: CNS Spectr. 2008 Jul;13(7 Suppl 11):4
references.pmid: 18622367
references.citation: Br J Psychiatry. 1979 Apr;134:382-9
references.pmid: 444788
references.citation: J Rheumatol. 2009 Feb;36(2):398-409
references.pmid: 19132781