Seroquel XL approved for depression

27 October 2010

Seroquel XL was launched in 2008 as a once-daily version of Seroquel.

Seroquel XL (prolonged-release quetiapine) has received approval as an add-on treatment for major depressive episodes in patients with major depressive disorder who have had a suboptimal response to antidepressant monotherapy.

Clinicians should consider the safety profile of prolonged-release quetiapine before initiating treatment. There is an increased risk of adverse events at higher doses; therefore, patients should be treated with the lowest effective dose and the need to increase the dose from 150mg/day to 300mg/day should be based on individual patient evaluation.

The use of prolonged-release quetiapine as an add-on to ongoing antidepressant therapy was assessed in two short-term (6-week) studies. A total of 919 patients were randomised to receive prolonged-release quetiapine 150mg or 300mg or placebo once daily; the primary endpoint was change at week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score.

At week 6, the rate of response (defined as a ≥50 per cent decrease in MADRS total score) was 53.7% and 58.3% for quetiapine 150mg/day and 300mg/day, respectively, versus 46.2 per cent for placebo (p=0.063 and p<0.01, respectively for the two doses versus placebo). Corresponding rates of remission (MADRS total score ≤8) were 35.6% (p<0.01), 36.5% (p<0.001) and 24.1%, respectively (p<0.01 and p<0.001, respectively for the two doses versus placebo).

The long-term efficacy and safety of prolonged-release quetiapine in major depressive disorders has been evaluated in adults as monotherapy, but not as add-on therapy.