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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Authors: Jean-Pierre Olié, David Gourion, Agnès Montagne, et al

Published Date March 2010 Volume 2010:6(1) Pages 71 - 79

DOI: http://dx.doi.org/10.2147/NDT.S10184

Jean-Pierre Olié¹, David Gourion², Agnès Montagne³, Michel Rostin⁴, Marie-France Poirier¹

¹Service de Santé Mentale et Thérapeutique, Centre Hospitalier Sainte-Anne, Paris, France; ²17 rue des Marronniers, 75016 Paris, France; ³Pierre Fabre Médicament, Labège, France; ⁴Pierre Fabre Médicament, Castres, France

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.

Keywords: major depressive episode, adult, serotonin and norepinephrine reuptake inhibitors, milnacipran, venlafaxine

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