Efficacy and safety of quetiapine combining valproate in the treatment of patients with acute manic episode of bipolar I disorder

Objective To explore efficacy and safety of quetiapine combining valproate in the treatment of patients with acute aminc episode of bipolar I disorder.Methods Sixty patients meeting the criteria of DSM-Ⅳ for Bipolar I disorder acute manic episodes were randomly divided into stduy group(n=30) treated with quetiapine combining valproate and control group(n=30) treated with quetiapine monotherapy for 6 weeks.Clinical efficacy was evaluated with Bech-Rafaelsen Mania Rating Scale(BRMS) and Clinical Global Impression(CGI),side effects was evaluated with Treatment Emergent Symptom Scale(TESS).Results Scores of BRMS at the 6th weekend in the two groups both decreased significantly compared with those at the baseline(P0.05).The decreasing rate of BRMS at the 1st weekend in study group was significantly higher than that in control group,and the difference lasted for the whole course of treatment(P0.05).At the end of the treatment,the recovery rate in study group was significantly higher than that in control group(P0.01).No serious adverse events happened in the two groups.There was no significant difference in dropout rate due to inefficacy and side effects.Conclusion The efficacy of quetiapine combining with valproate is better than that of valproate monotherapy in treatment of acute aminc episode of bipolar I disorder.The combining therapy takes effect more quickly and its safety is good.