The second phase clinical trials of reboxitine for the treatment of the major depressive disorder

Objective The aim of this study was to determine the efficacy and safety of reboxitine for the depressive patients.Methods A controlled study was carried out in 46 patients who met the CCMD-3 criteria of major depression and depressed episode.22 of total patients were treated with reboxitine(8mg/d)and the others were treated with fluoxetine (20mg/d)for 6 weeks.The efficacy was assessed by Hamilton Depression Rating scale(HAMD),Hamilton Anxiety scale(HAMA),Clinical Global Impression(CGI)and the safety was assessed by adverse event.Results After six weeks treatment,the improvement rate of reboxitine group and fluoxetine group were 69.57% and 76.00%,respectively(P0.05).The scores of HAMD and HAMA in two groups were statistically different before and after treatment(P0.01).The main adverse events of two groups were dry mouth,hidrosis,nausea,constipation.There was no significant difference in incidence of adverse events between reboxitine and fluoxetine groups.Conclusions Reboxitine is an effective antidepressants,with better safety,suiting for clinical use.