Ziprasidone plus a mood stabilizer in subjects with patients with manic or mixed episode of bipolar disorders

AIM:To explore efficacy and safety of ziprasidone combining lithium carbonate or valproate in the treatment of patients with manic and mixed episode of bipolar disorders. METHODS:The 68 patients meeting criteria of manic episode or mixed episode of bipolar disorder in CCMD-3 were randomly divided into experiment group(combination of ziprasidone and lithium carbonate or valproate) and control group(single using of lithium carbonate or valproate) and observed for 6 weeks.The Yong Manic Rating Scale(YMRS) and treatment emergent symptom scale(TESS)were individually used for the assessment of efficacy and safety. RESULTS:The score of YMRS was decreased significantly in the both groups after treatment(F=9.05,P0.01;F=6.10,P0.01).And the score of YMRS at 1st weekend in experiment group was significantly higher than that in control group,and this difference sustained for 6 weeks.The cure rate in experiment group was higher than that in control group after treating for 6 weeks.The scores of YMRS in experiment group were 21.4±8.4,14.6±5.5,8.9±3.3,6.5±3.4,respectively at 1 weekend,2 weekend and 3 weekend;and the scores of YMRS in control group were 23.9±7.2,20.9±8.1,17.8±7.8,12.8±8.9,respectively.There was significant difference between the experiment group and control group(P0.01).The changes of decreasing score of symptoms were in experiment group 6.1±3.5,12.9±4.8,20.1±5.3,21.4±5.5;and the changes of decreasing score of symptoms in control group were 2.1±3.0,6.8±4.5,11.5±5.6,14.4±5.3,respectively.There was significant difference between the experiment group and control group(P0.01).The effective rate and cure rate in experiment group was significantly higher than that in control group(68.5% vs 48.5%,χ2=4.47,P0.05;54.3%vs 18.2%,χ2=9.52,P0.01).Both groups have not serious side effects.There were no difference in dropout rate due to less efficacy and side effects. CONCLUSION:The effects of ziprasidone combination with lithium carbonate or valproate in the treatment of manic episode and mixed episode of bipolar disorder is better than that of single lithium carbonate or valproate.