A randomized,double blind,and parallel controlled multicenter clinical trial of reboxetine in treatment of depression

AIM To evaluate the efficacy and safety of reboxetine in adult patients with depression. METHODS In this randomized,double blind,fluoxetine parallel controlled,multicenter clinical trial,240 patients were randomly divided into reboxetine group and fluoxetine group at the ratio of 1:1.The daily dose of reboxetine and fluoxetine was 4 mg and 10 mg respectively in the first 3 days,and then from the 4th day the daily dose was 8 mg and 20 mg respectively.The treatment period was 6 weeks.At the end of wk 1,2,4,and 6,HAMD17,HAMA,CGI-I,and CGI-S were used to assess the therapeutic efficacy.Safety evaluation indicators included the adverse reactions,as well as physical,vital signs,electrocardiograph examination,and clinical laboratory tests at the baseline and the end of the trial or the premature cessation.RESULTS The patients of the reboxetine group and the fluoxetine group were 118 and 117 in the intent-to-treat set,110 and 108 in the per-protocol set,and 120 and 117 in the safety analysis set.At the end of wk 1,2,4,and 6,the HAMD17 scores and reduction rates had no significant difference between the two groups(P0.05).The reduction rates of HAMA scores at the end of wk 1 had very significant difference between the two groups(P0.01),with no difference at the other time points(P0.05).At the end of wk 6,there was no significant difference in the effective(reduction rate of HAMD≥50%) rates and cure(total HAMD score≤7) rates between the two groups.The adverse reaction rates between the two groups had no significant difference(P0.05).The main adverse reactions of reboxetine contained dizziness,dry mouth,constipation,and dysuria, but they all emerged in the early stage and were mild,transient,and could be alleviated when no drug administration.CONCLUSION Reboxetine have the same efficacy and safety as fluoxetine in treating depression,and reboxetine has a much more rapid onset than fluoxetine especially in improving anxiety.