Objective:To evaluate and compare the efficacy and safety of Shugan Jieyu capsules and hydrochloride Venlafaxine capsules in the treatment of depression. Methods:Totally 50 cases of patients with depression were randomly divided into the observa-tion group (n=26) and the control group (n=24). The observation group was treated with 2 Shugan Jieyu capsules in the morning and in the evening, while the control group was treated with hydrochloride Venlafaxine capsules at the dose of 75-150 mg·d-1,six weeks as a course of treatment. Hamilton Depression Scale ( HAMD) and Treatment Emergent Symptom Scale ( TESS) were used in the evaluation before the treatment and 2, 4 and 6 weeks after the treatment. Results:HAMD scores of the two groups were significant-ly decreased after the treatment (P<0. 01), and the scores were gradually decreased with the treatment, and there were no significant differences between the two groups (P>0. 05). The total efficacy of Shugan Jieyu capsules and hydrochloride Venlafaxine capsules was 88. 46% and 87. 5%, respectively, and there was no significant difference (P>0. 05). TESS scores of the observation group were significantly lower than those of the control group after the 2, 4 and 6-week treatment (P<0. 01). The incidence of adverse reactions of Shugan Jieyu capsules (42. 31%) was obviously lower than that of hydrochloride Venlafaxine capsules (70. 83%, P<0. 01). Con-clusion:Shugan Jieyu capsules are safe and effective in the treatment of depression.