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Many patients with bipolar disorder do not fare consistently well, even when taking first-line medications such as lithium and divalproex. To see if initial treatment of quetiapine plus lithium or divalproex prevents recurrences among clinically stabilized patients, investigators conducted a multisite, industry-funded, two-phase study of 1953 bipolar patients with current manic, depressed, or mixed states.
Patients first underwent open-label treatment with flexibly dosed quetiapine (400–800 mg/day) combined with lithium or divalproex. Patient selection was not based on failure to respond to monotherapy. Of 1938 patients who began treatment, 1387 (72%) experienced drug-related adverse events, causing 404 (20%) to withdraw.
After 12 weeks, 628 …