Seroquel XR (quetiapine fumarate extended-release tablets, from AstraZeneca) has been approved by the FDA as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD). This approval was based on clinical data from two Phase 3, placebo-controlled studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR as adjunctive treatment in 939 patients with MDD who had an inadequate response to their antidepressant therapy. In both studies efficacy with Seroquel XR was superior to placebo, as assessed by the primary endpoint, which was the change from baseline to end of treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Seroquel XR is already indicated in adults as monotherapy for acute manic or mixed episodes in bipolar I disorder, or as an adjunct to lithium or valproate for acute manic or mixed episodes and maintenance treatment; for depressive episodes associated with bipolar disorder; and for schizophrenia.

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