Anglo-Swedish drug major AstraZeneca presented results demonstrating the efficacy and tolerability of Seroquel (quetiapine) for treating depressive episodes in bipolar disorder, including the difficult-to-treat bipolar II patient population, at the American Psychiatric Association congress in San Francisco.
Results from a combined analysis of all patients with bipolar I or II disorder (n=2593) demonstrated that Seroquel monotherapy was significantly more effective than placebo for treating depressive episodes associated with bipolar disorder (p<0.001 for both doses of Seroquel).
Similar results were observed in a combined analysis of patients with bipolar II disorder (n=819). In both analyses, improvements were evident as early as week one and continued through week eight. The four studies, BOLDER I and II and EMBOLDEN I and II, had a similarly designed eight-week, randomized, double-blind, placebo-controlled phase to evaluate the efficacy and safety of Seroquel monotherapy (fixed dose 300mg or 600mg daily) compared with placebo in adult patients with bipolar I or II disorder. The EMBOLDEN studies also included an active comparator arm, lithium in EMBOLDEN I and paroxetine in EMBOLDEN II.
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