A phase II randomized,double blind, multi-centers and parallel control clinical trial for bupropion SR in the treatment of depressive disorders

Objective:To evaluate the efficacy and safety of bupropion made in China for the treatment of depressive disorders. Methods:237 patients with depressive disorders enrolled in a randomized, double blind, multi-center, parallel control clinical study were randomized orally to receive either bupropion 150～450 mg daily (n=119) or fluoxetine 10～30 mg daily (n=118) for 6 weeks. Hamilton Depression Rating Scale and Clinical Global Impression were used to evaluate the efficacy. The Treatment Emergent Symptom Scale was used to assess the safety. Results:The HAMD scores and CGI scores in both groups showed significant reductions at the end of therapy in comparison with the baselines(P 0. 05). The overall efficacy rate of bupropion and fluoxetine were 70.69% and 74. 14% , respectively (P0.05). The incidence rate of adverse events the bupropion-treated and fluoxetine-treated patients experienced were 41.4% and 44. 8% , respectively (P0.05). Conclusion; Bupropion provided an alternative therapeutics against depressive episodes.