Objective: To evaluate the safety and efficacy of Wuling Capsule combined with Deanxit in treating post-stroke depression (PSD).Methods: One hundred and fourteen patients with PSD were randomly divided into Wuling Capsule-treated group (n=39), Deanxit-treated group (n=37) and Wuling Capsule plus Deanxit-treated group (n=38). Patients in Wuling Capsule-treated group were administered with three Wuling Capsules three times a day, and patients in Deanxit-treated group were administered with Deanxit 10.5 mg twice daily, while patients in the Wuling Capsule plus Deanxit-treated group were administered with both Wuling Capsule and Deanxit. Patients in the three groups were all treated for six weeks. Treatment efficacy was evaluated with Hamilton Depression Scale (HAMD) and the side effects were evaluated with Treatment Emergent Symptom Scale (TESS) before treatment and after 2-, 4-, and 6-week treatment. The blood and urine routine examinations were performed, and the hepatorenal functions and electrocardiogram were examined as well.Results: There was no statistical difference in the total efficacy rate between Wuling Capsule-treated group and Deanxit-treated group (64.1% vs 64.9%, P>0.05), but the total efficacy rate of Wuling Capsule plus Deanxit-treated group was higher than that of the monotherapy (89.5% vs 64.1%, 89.5% vs 64.9%, P＜0.05). There were no significant side effects in Wuling Capsule-treated group, while the incidence of side effects was 9% in both groups administered with Deanxit.Conclusion: The efficacy of Wuling Capsule plus Deanxit is better than that of the monotherapy in treating PSD.

Key words: apoplexy, antidepressants, depressive disorder, randomized controlled trial