Effect of once-daily extended release Quetiapine Fumarate (Quetiapine XR) as add-on to antidepressants in major depressive disorder (MDD)

Abstract

Objective:To evaluate the efficacy and tolerability of once-daily quetiapine XR adjunctive to antidepressant therapy versus antidepressant alone in patients with MDD showing an inadequate response to antidepressant treatment (mainly SSRIs/SNRIs).Methods:6-week, multicentre, double-blind, parallel-group study (D1448C00007). Patients were randomised to receive quetiapine XR 150mg/day (n=167), 300mg/day (n=163) or placebo (n=163) as add-on to maintained antidepressant treatment. Primary endpoint: baseline to Week 6 change in MADRS total score. Secondary variables included: baseline to Week 1 change in MADRS total score; baseline to Week 6 change in HAM-A total and psychic anxiety subscale scores. Safety assessments included AE reporting.Results:Mean change in MADRS total score (overall baseline mean, 28.4) from baseline to Week 6 was significant (p<0.01) for quetiapine XR 150mg/day (-15.26) and 300mg/day (-14.94) versus placebo (-12.21). Separation from placebo in MADRS total score was apparent from Week 1 for both quetiapine doses (p<0.001).At Week 6, mean change from baseline in HAM-A total score (overall baseline mean, 20.8) was significant for quetiapine XR 150mg/day (-10.27, p<0.01) and 300mg/day (-9.70, p<0.05) versus placebo (-7.92). Mean change from baseline in HAM-A psychic anxiety subscale score (overall baseline mean, 12.83) was significant with quetiapine XR 150mg/day (-6.82, p<0.001) and 300mg/day (-6.47, p<0.01) versus placebo (-5.11).Most common AEs (>10%) were dry mouth, somnolence, fatigue, sedation, constipation and dizziness with quetiapine XR.Conclusion:In patients with MDD with an inadequate response to antidepressant treatment, adjunctive quetiapine XR 150mg/day and 300mg/day was well tolerated and effective at reducing depressive and anxiety symptoms.

Switching Antidepressants vs. Conventional Augmentation Strategies

“…One study 28 found the 300 mg dose to be more effective than placebo, but not the 150 mg dose. The second study 27 showed that both doses were more effective than placebo. Although quetiapine appears to be an effective adjunctive agent for MDD, minimally effective and optimal doses of quetiapine for this indication remain unclear.…”

“…Two other studies 27,28 focused on the use of quetiapine augmentation of antidepressants. These studies examined two separate doses of quetiapine (150 mg or 300 mg).…”