The second phase clinical trials of bupropion SR for the treatment of the major depression

Objective The aim of this study was to determine the efficacy and safety of bupropion SR for the depressive patients.Methods A controlled study was carried out between 66 patients who met the CCMD-3 criteria of major depression and depressed episode.34 of total patients were treated with bupropion SR(300 mg/d),and the others were treated with fluoxetine(20 mg/d)for 6 weeks.The efficacy were assessed by Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Scale(HAMA),and Clinical Global Impression(CGI),and the safety was assessed by Treatment Emergent Symptom Scale(TESS).Results After six weeks treatment,the improvement rate of bupropion SR group and fluoxetine group were 76.47% and 75.00% 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 nausea,dry mouth,dizziness,insomnia,diaphoresis,anorexia,and constipation.There was no significant difference in incidence of adverse events between bupropion SR group and fluoxetine group.Conclusions Bupropion SR is an effective and safe antidepressant.