A double-blind, placebo-controlled study with quetiapine as adjunct therapy with
lithium or divalproex in bipolar I patients with coexisting alcohol dependence.
Author(s): Stedman M, Pettinati HM, Brown ES, Kotz M, Calabrese JR, Raines S.
Affiliation(s): Stedman Clinical Trials, 3212 Cove Bend Dr., Tampa, FL 33613, USA.
marystedman@tampabay.rr.com
Publication date & source: 2010, Alcohol Clin Exp Res. , 34(10):1822-31
BACKGROUND: This study evaluated the efficacy of quetiapine versus placebo as an
adjunct to lithium or divalproex in reducing alcohol consumption in patients with
bipolar I disorder and coexisting alcohol dependence.
METHODS: Male and female outpatients (21 to 60 years) with a history of bipolar I
disorder and alcohol dependence were included in this 12-week, placebo-controlled
study. Patients treated with lithium or divalproex (ongoing or assigned at
screening) were randomized to receive quetiapine (dosed up to 400 mg/d over 7
days, followed by 300 to 800 mg/d flexible dosing until study end) or placebo.
The primary outcome measure was the change in the proportion of heavy drinking
days from baseline to Week 12 (as derived from the Timeline Followback method).
Secondary outcome measures included time to the first consecutive 2 weeks of
abstinence, changes from baseline to Week 12 in the proportion of nondrinking
days, mean number of standardized drinks per day, and Clinical Global
Impressions-Severity of Illness score.
RESULTS: Of 362 enrolled patients (mean 38.6 years), 176 were randomized to
receive quetiapine and 186 to placebo. The mean proportion of heavy drinking days
at baseline was 0.66 in the quetiapine group and 0.67 in the placebo group. At
Week 12, the mean change in the proportion of heavy drinking days was -0.36 with
quetiapine and -0.36 with placebo (p = 0.93). No statistically significant
differences in any of the secondary outcome measures were noted between the
quetiapine and placebo groups. The incidence of adverse events was consistent
with the previously known tolerability profile of quetiapine.
CONCLUSIONS: The efficacy of quetiapine in the treatment of bipolar disorder is
already well established. In this study, however, quetiapine added to lithium or
divalproex did not result in significantly greater improvement compared with
placebo in measures of alcohol use and dependence in patients with bipolar I
disorder and alcohol dependence.
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