The Third Phase Clinical Trials of Jinyukang for the Treatment of Mild to Moderate Depressive Disorders

Objective To determine the efficacy and safety of Jinyukang to the patients with mild to moderate depressive disorders.Methods A controlled study was carried out among 90 patients who met the CCMD-3 criteria of depression and depressed episode.All the patients were divided into three groups:the low-dose Jinyukang(600mg/d),the high-dose Jinyukang(750mg/d)and the fluoxetine(20mg/d),and were treated for 6 weeks.The efficacy was assessed by Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Scale(HAMA),and Clinical Global Impression(CGI)and the safety was assessed by Adverse Event.Results After six-week treatment,the improvement rate of the low-dose Jinyukang,the high-dose Jinyukang and the fluoxetine were 80.00%,76.67%,76.67%,respectively(P 0.05).The scores of HAMD and HAMA in three groups were statistically different before and after treatment(P0.01).The main adverse events of three groups were nausea,dry mouth,insomnia,et al.there were no significant differences in incidence of adverse events among them.Conclusions Jinyukang is an effective antidepressants,with less side effects,better safety,suiting for clinical use.