[Open randomized comparative twelve-week study of lithium and valproate in manic episode]

Abstract

One hundred and twenty-five patients (49 men and 76 women, mean age 38,0+/-12,5 years) were randomized in two groups. One group (64 patients) was treated with valproate sodium and another group (61 patients) received lithium carbonate. Monotherapy was administered with the mean dose of valproate 20 mg/kg/day (serum valproate concentration between 70 and 125 ?g/ml) and the mean dose of lithium 800 mg/day (between 600 and 900 mg/day; serum lithium concentration 0,8-1,2 mmol/L) during 12 weeks. Clinical effectiveness was assessed using YMRS, CGI-BP and MADRS at 0, 5th, 10th, 21st , 84th days of treatment. The number of responders (50% reduction in YMRS scores) was 51,7% (30 patients) in lithium group and 56,7% (34 patients) in valproate group by the 21st day (p=0,59).The mean reduction in YMRS scores was 11,6 in patients treated with lithium and 12,3 in patients treated with valproate. By the 84th day (LOCF), the number of responders reached 85% (51 patients) in lithium group and 90,3% (56 patients) in valproate group (p=0,37). The mean reduction in YMRS scores was 19,4 in patients treated with lithium and 19,6 in patients treated with valproate. The average reduction in MADRS scores was -1,4 (p=0,08) and -2,2 (p=0,001) in lithium group; -1,6 (p=0,002) and -1,4 (p=0,019) in valproate group on the 21st and 84th days. Adverse effects were observed in 8 (13,1%) patients who received lithium and 3 patients (4,7%) who received valproate (p=0,12). The most common of them were tremor, nausea, dry mouth. There were no clinically significant abnormalities in laboratory values, vital functions and EEG. In conclusion, the results demonstrated equal therapeutic efficacy, tolerability and safety of valproate and lithium in the treatment of manic episodes in patients with bipolar disorder.