We propose to test the efficacy of sodium valproate in the acute and early maintenance phases of treatment for patients with alcoholism and comorbid bipolar disorder in a double-blind, placebo-controlled, and randomized, parallel group trial. With nearly one million affected individuals in the U.S., comorbid alcoholism and bipolar disorder in a double-blind, placebo- controlled, and randomized, parallel group trial. With nearly one million affected individuals in the U.S., comorbid alcoholism and bipolar disorder represent a significant public health challenge. The presence of comorbidity has a significant public health challenge. The presence of comorbidity has a significant negative impact on treatment response and outcome resulting in increased risk for suicide, and increased rates of costly inpatient psychiatric care. Pharmacologic treatment addressing concurrently these dual disorders is non-existent. Our proposed intervention is based on Past and coworkers theoretical model of kindling and behavioral sensitization hypothesized to underlie the mechanisms of both the recurrent and progressive course of bipolar illness and that of alcohol withdrawal/craving states. This model has formed the basis for the successful use of anti-convulsant, anti-kindling agents in the treatment of bipolar disorders and its applicability to bipolar alcoholics is highly relevant. We request five years of support to achieve the following aims: 1) Examine the efficacy of sodium valproate plus a procedurally specified Treatment-As-Usual (TAU = lithium carbonate + counseling) condition compared to a placebo plus TAU in the stabilization of acute manic episodes in patients with comorbid DSM-IV alcohol dependence; 2) Assess specific predictors of medication response, and; 3) Conduct a prospective assessment of the effects of the severity of alcohol use on mood symptoms. Ninety-four subject (n=47 for each group) will be recruited, randomized and stabilized on pharmacotherapy on the inpatient units and prospectively followed, with biweekly assessment, for 6 months of outpatient care. This research is likely to lead to more effective pharmacologic treatment of patients with alcoholism and bipolar disorders and help to increase our knowledge of predictors of treatment response in this high risk clinical population.
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