Randomized, double blind, double-dummy, multicenter, parallel controlled clinical trial of Kaiyuanshen in the treatment of depressive disorder

Objective To evaluate the efficacy and safety of Kaiyuanshen in the treatment of depressive disorders.Methods This is a randomized, double blind, double-dummy, multicenter, parallel positive controlled clinical trial for 6 weeks. Two hundreds and eighty-nine patients who met with the including criteria were enrolled, 144 cases in Kaiyuanshen group, 145 cases in fluoxetine group. The daily dose of Kaiyuanshen and fluoxetine are 1440 mg and 20 mg, respectively. Results Both groups endpoint Hamilton depression rating scale (HAMD) score reduced significantly in comparison with the baseline(P0.05).By the HAMD score reduction rate, the clinical effective rate of Kaiyuanshen was 67.14 %, fluoxetine was 66.20%. There is no significant difference between two groups. The adverse reaction of Kaiyuanshen are lower than fluoxetine(19.86% vs 35.21%,P0.05). The laboratory examination of two groups did not shown any biochemical abnormality. Conclusion Kaiyuanshen is a novel anti-depressive agent with well efficacy and safety.