A random,blinded and controlled trial for evaluating the efficacy and safety of olanzapine and lithium in the treatment of bipolar or mixed type mania

Objective:To compare the clinical efficacy and safety of olanzapine with those of lithium in the treatment of bipolar or mixed type mania.Methods:Sixty inpatients with bipolar or mixed type mania were treated to olanzapine or lithium in a 4-week random,blinded and controlled trial.To assess the efficacy and side effects, Clinical Global Impression-BP(CGI-S-BP),Young Mania Rating Scale(YMRS),Brief Psychosis Rating Scale (BPRS),and Montgomery-(?)sberg Depression Rating Scale(MADRS)were used before and after treatment for 1, 2,3,4 weeks.The changes of biochemical index,blood tests,urine tests and electrocardiogram were determined before and at the end of treatments.Results:After treatment with olanzapine or lithium for 4 week,the scores of CGI-S-BP were significantly decreased from(5.4±0.77)and(5.1±0.70)to(2.2±1.21)and(2.3±1.10) (P0.01);YMRS from(33.5±8.13)and(31.6±7.69)to(7.6±10.09)and(6.7±6.79)(P0.01); BPRS from(13.5±7.41)and(14.5±9.20)to(3.8±6.53)and(3.9±4.92)(P0.01).However,there were no significant difference between the effects of two drugs(P0.05).After 6-week treatment of olanzapine and lithium,the respond rate(85.7% and 84.4%)and remission rate(82.1% and 81.3%)were similar.There was no significant difference in TEAEs between two groups,and no abnormalities of electrocardiogram were found in olanzapine group.Conclusion:The efficacy of olanzapine is the same as that of lithium in the treatment of bipolar or mixed type mania,but its safety is higher.