Pooled Analysis of Adjunctive Extended Release Quetiapine Fumarate (Quetiapine XR) in Patients with Major Depressive Disorder (MDD)

Abstract

Aim:

To evaluate quetiapine XR as adjunct to ongoing antidepressant therapy in patients with MDD showing inadequate response to antidepressant treatment.

Methods:

Data were analysed from two 6-week, multicentre, double-blind, randomised, placebo-controlled studies (D1448C00006; D1448C00007), prospectively designed to be pooled. Outpatients received adjunctive quetiapine XR 150mg/day (n=309), 300mg/day (n=307), placebo (n=303). Primary endpoint: change at Week 6 in MADRS total score. Other assessments included: MADRS individual item scores, HAM-A total scores, MADRS response and remission; AE reporting.

Results:

Quetiapine XR 150mg/day and 300mg/day (p< 0.001) reduced MADRS total scores versus placebo at Week 6 (-14.5, -14.8, -12.0) and Week 1 (-7.8, -7.3, -5.1). Subgroup analyses showed the therapeutic effect of quetiapine XR was neither limited to nor driven by factors such as gender or antidepressant class (SSRI/SNRI). Quetiapine XR demonstrated consistent improvements in individual MADRS items: 150mg/day and 300mg/day significantly improved 4/10 and 7/10 items at Week 6 versus placebo. At Week 6, MADRS response (≥50% decrease in total score) was 53.7% (p=0.063), 58.3% (p< 0.01) versus 46.2%; MADRS remission (total score ≤8) was 35.6% (p< 0.01), 36.5% (p< 0.001) versus 24.1% for quetiapine XR 150mg/day and 300mg/day and placebo, respectively. Quetiapine XR 150mg/day and 300mg/day improved HAM-A total scores versus placebo at Week 1 (-4.8 [p< 0.001], -4.2 [p< 0.01], -3.0) and Week 6 (-8.9 [p< 0.01], -9.1 [p< 0.001], -7.3). AEs (≥10%) were dry mouth, somnolence, sedation, dizziness, fatigue, constipation and headache with quetiapine XR.

Conclusion:

In patients with MDD and an inadequate response to antidepressant therapy adjunctive quetiapine XR is effective and generally well tolerated.