A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders

Objective: Alcohol dependence is extremely common in patients with bipolar disorder, and it is associated with unfavorable outcomes, including treatment nonadherence, violence, and cognitive impairment. However, few treatment trials have been conducted in this population. Quetiapine is an atypical antipsychotic medication that is used to treat the mood symptoms of bipolar disorder. In this study, the efficacy of quetiapine in reducing alcohol use and improving mood symptoms was assessed in patients with bipolar disorder and alcohol abuse or dependence. Method: One hundred fifteen outpatients with bipolar disorder and alcohol abuse or dependence were randomly assigned to 12 weeks of quetiapine (titrated to 600 mg/day) add-on therapy or placebo. Alcohol use and mood were assessed. The study was conducted from November 2002 to September 2005. Results: One hundred two participants (49% with bipolar I disorder, 82% depressed, and 97% with alcohol dependence) returned for at least 1 postbaseline assessment and were used in the random regression analysis. No statistically significant between-group differences were found on alcohol use measures or the Young Mania Rating Scale. However, based on a random regression analysis, scores on the Hamilton Rating Scale for Depression (HAM-D) decreased statistically significantly more in the quetiapine than in the placebo group during the trial (p < .05). The between-group difference was largely due to differences in HAM-D scores during the first 6 weeks of the trial, with the placebo group showing greater improvement during the second half of the trial. Conclusions: Quetiapine therapy was associated with a statistically significant decrease in depressive symptoms, but not alcohol use, in patients with bipolar disorder and alcohol dependence (p < .05). Trial Registration: clinicaltrials.gov Identifier: NCT00223249