Primary Aim:~To compare the efficacy of LI, DVP, and PBO in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: DVP = LI > PBO.~Secondary Aims:~To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI, DVP, or LI + DVP.~To collect data on possible predictors of acute treatment response to the two active treatments.~To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment.~To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer.
This study will compare the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.