Agomelatine Combined With Escitalopram For The Acute Phase Of Major Depressive Disorder:A Randomized Controlled Study

ObjectiveTo evaluate the efficacy and safety of agomelatine combined with escitalopram in the acute phase of major depressive disorder(MDD).To investigate whether there is a potentiating effect of agomelatine combined with escitalopram and whether agomelatine combined with escitalopram has an improving effect on anhedonia and cognitive function.MethodsOne hundred and eighty patients in the acute phase of MDD were randomly divided into agomelatine combined with escitalopram treatment group(hereafter referred to as A group),agomelatine treatment group(hereafter referred to as B group),and escitalopram treatment group(hereafter referred to as C group).Condition severity was assessed using the Hamilton Depression-17-items scale(HAMD-17)and Hamilton Anxiety Scale(HAMA)at the baseline,at the end of 3 and at the end of 6 weeks.Severity of anhedonia was assessed at the baseline,at the end of 3 and at the end of 6 weeks using the Chinese version of the Chinese version of the Snaith-Hamilton Pleasure Scale(SHAPS).Cognitive function was assessed using the Thinc-it tool(PDQ-5D,CRT,N-back,DSST,TMT-B)at the baseline and the end of 6 weeks.Adverse reactions were assessed using the Asberg Side-effect Rating Scale for Antidepressants(SERS)at the end of 3 and 6 weeks.Results1.Comparison of the efficacy of the three groups(1)Comparison of the efficacy between group A and group B:At the end of 6 weeks,the rate of HAMD-17 scores reduction in group A was higher than that in group B[(49.44±10.81)%and(37.56±13.71)%,P<0.017)].(2)Comparison of the efficacy between group A and group C:At the end of 6 weeks,the rate of HAMD-17 scores reduction in group A was higher than that in group C[(49.44±10.81)%and(41.93±13.16)%,P<0.017)].(3)Comparison of the efficacy between group B and group C:At the end of 6 weeks,the difference between the rate of HAMD-17 scores reduction in group B and that in group C was not statistically significant[(37.56±13.71)%and(41.93±13.16)%,P>0.017)].2.Comparison of the three treatment regimens for improving symptoms of anhedoniaAt the end of 6 weeks,the SHAPS scores was 24.07±3.40 in group A,24.92±2.55 in group B,and 26.63±2.16 in group C.The SHAPS scores decreased in all three groups compared with the baseline,and the differences were statistically significant(all P<0.05).The difference in the SHAPS scores among the three groups was statistically significant(P<0.05).Post-hoc multiple comparison analysis showed further that the differences between groups A and B were not statistically significant(P>0.05),between groups A and C were statistically significant(P<0.05),and between groups B and C were statistically significant(P<0.05).3.Comparison of the three treatment regimens for improving cognitive functionAt the end of 6 weeks,the PDQ-5D,CRT,N-back,DSST,and TMT-B scores were higher in all three groups than the baseline,and the differences were statistically significant(all P<0.05).Group A had higher scores on PDQ-5D,CRT,and N-back than group C,and the differences were all statistically significant(all P<0.05).Group B scored higher on PDQ-5D and N-back than group C,and the difference was statistically significant(all P<0.05).There was no statistically significant difference in PDQ-5D,CRT,N-back,DSST,and TMT-B in group A compared with group B(P>0.05).4.Assessment of the safety and shedding rates of the three treatment regimensThere was no statistically significant difference in the incidence of adverse reactions among the three groups of patients(P>0.05).No statistically significant difference in the rate of shedding among the three groups(P>0.05).Conclusion1.The efficacy of agomelatine combined with escitalopram in treating patients with MDD in the acute phase was superior to that of treatment with agomelatine or escitalopram alone,and the efficacy of agomelatine and escitalopram was comparable.2.Treatment with agomelatine combined with escitalopram improved symptoms of anhedonia in patients with MDD in the acute phase better than treatment with escitalopram alone.It was comparable to treatment with agomelatine alone.Agomelatine alone was superior to treatment with escitalopram alone in improving symptoms of anhedonia.3.Treatment with agomelatine combined with escitalopram improved cognitive function in patients with MDD in the acute phase better than treatment with escitalopram alone.It was comparable to treatment with agomelatine alone.Agomelatine alone was superior to treatment with escitalopram alone in improving cognitive function.4.Agomelatine combined with escitalopram treatment,agomelatine treatment alone,and escitalopram treatment alone in the acute phase of MDD all had a high and comparable safety,all with promising compliance within a short period of treatment(6 weeks).