Abstract: OBJECTIVE To evaluate the efficacy and safety of the traditional Chinese medicine Jieyutang in treatment of depressive disorder. METHODS Patients with depressive disorder (the HAMD-17 score ≥17) who have not recovered after 4 weeks paroxetine treatment (the HAMD-17 score≥14) were divided into two groups randomly and received traditional Chinese medicine Jieyutang combined with paroxetine treatment or paroxetine treatment for 8 weeks respectively. The Hamilton Rating Scale for Depression(HAMD-17), Life Satisfaction Rating Scale(LSR) and Treatment Emergent Symptoms Scale (TESS) were used to measure therapeutic efficacy and side effects. RESULTS 65 patients (intent to treat, ITT) were randomized into two groups (32 patients in combined treatment group, and 33 in paroxetine group). In ITT, per protocol (PP) set was 60 patients (30 in each group). After 8 weeks treatment, the effective rate of combined treatment and paroxetine group was 83% and 67%, respectively (P<0.05). The total and factors scores of HAMD-17 decreased significantly at 2, 4, 6 and 8 weeks after Jieyutang combined with paroxetine treatment or paroxetine treatment (P<0.01). There was significant difference on the total scores of HAMD-17 at 4, 6 and 8 weeks after treatment and the retardation factor score at 8 weeks after treatment and sleep disturbance factor score at 6 and 8 weeks after treatment between two groups. The LSR scores decreased significantly at 4, 6 and 8 weeks after treatment on two groups (P<0.01). There was significant difference on the scores of LSR between two groups after 6 and 8 weeks treatment. There was no significant difference on the total TESS after treatment between two groups. CONCLUSION Jieyutang combined with paroxetine treatment was more effective than only paroxetine treatment and on the improvement of retardation, sleep disturbance and Life satisfaction. The safety of Jieyutang combined with paroxetine treatment was higher and has less side effects.