OBJECTIVE: To determine the effects of Anshendingzhi decoction(ASDZD) on depression, to com-pare ASDZD with Danzhixiaoyao pill(DZXYP), and to provide evidence for the clinical treatment of depression with Traditional Chinese Medicine.METHODS: Seventy-eight patients with depression were enrolled from 2011 to 2013 in this double-blinded study. Patients were randomly divided into two groups: ASDZD(treatment group, n=39)and DZXYP(control group, n=39). Hamilton Depressive Scale and TCM Syndrome Differentiation Scale were used to assess depression and efficacy before treatment and 2, 4, and 6 weeks after treatment.The Treatment Emergent Symptoms Scale(TESS)was used to evaluate adverse reactions, observe,and record treatment outcomes.RESULTS: ASDZD was significantly more effective than DZXYP. There were significant differences between the two groups in terms of recovered patients, overall response rate, and TESS score(all P