A PILOT-STUDY OF LITHIUM-CARBONATE PLUS DIVALPROEX SODIUM FOR THE CONTINUATION AND MAINTENANCE TREATMENT OF PATIENTS WITH BIPOLAR-I DISORDER

Background: This pilot study compared the efficacy of lithium plus div alproex sodium with the efficacy of lithium alone for the continuation and maintenance treatment of patients with bipolar I disorder. Method : Twelve patients with bipolar I disorder as defined by the DSM-III-R were recruited and followed prospectively for up to 1 year. Each subje ct received lithium at serum levels of 0.8 to 1.0 mmol/L and a managem ent/education session weekly or every 2 weeks. By random assignment, s ubjects received either divalproex sodium or placebo in conjunction wi th lithium. Divalproex sodium was adjusted to achieve a serum concentr ation of 50 to 125 mu g/mL. Adjunctive medications were used on an as needed basis to treat psychosis, depression, and anxiety. The course o f illness was monitored through use of the Longitudinal Interval Follo w-up Examination. Results: Subjects treated with the combination of li thium and divalproex were significantly less likely to suffer a relaps e or recurrence (p=.014), but were significantly more likely to suffer at least one moderate or severe adverse side effect (p=.041). There w as no significant difference between groups in the use of adjunctive m edication. Conclusion: These results provide preliminary evidence of t he risks and benefits of combining lithium with divalproex sodium for the continuation and maintenance treatment of bipolar I disorder.