A comparison in efficacy and safety of milnacipran with fluoxetine in Chinese patients with major depressive disorder

AIM To compare the efficacy and safety of milnacipran versus fluoxetine in Chinese patients with major depressive disorder.METHODS This was a 6-week,multicenter,randomized,double-blind, fluoxetine-controlled,parallel-group study.The dose of milnacipram was 100 mg·d~(-1)(po,bid) in milnacipram group and that of fluoxetine was 20 mg ? d~(-1)(po,qd) in fluoxetine group.The primary endpoint was the reduction of total scores of Hamilton Depression Scale 17-item(HAMD-17) from baseline to week 6,while other efficacy assessments included Hamilton Anxiety Scale(HAMA) and Clinical Global Impression(CGI). Adverse event data were collected throughout the study.RESULTS Full analysis set(FAS) included 117 and 119 patients in milnacipran and fluoxetine groups,respectively.A total of 18 patients did not complete the 6-week study,12 in the milnacipran group and 6 in the fluoxetine group.At the end of the treatment,the HAMD- 17 total score decreased(14.2±5.4) and(14.3±6.0) in milnacipran group and fluoxetine group, respectively.There were no significant differences of HAMD-17 total scores between the two groups at any visit time.The response rate in milnacipran group and fluoxetine group was 79.5%and 74.8%,the remission rate was 53.0%and 45.4%,respectively(P0.05).There were no significant differences in HAMA,CGI-S and CGI-I scores between the two groups.There were 16.7%(20/120) and 21.7%(26/120) patients experienced adverse events in milnacipran and fluoxetine groups,respectively(P0.05).The most common adverse events were dizziness(5.0%),nausea(4.2%) and dry mouth(2.5%).No severe adverse events happened throughout the study.CONCLUSION Milnacipran(50 mg,bid) was shown to be clinically effective in Chinese patients with major depression and comparable to fluoxetine(20 mg,qd),and the medications were well tolerated.