937: Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: A randomized, placebo-controlled clinical trial (study 003)

BACKGROUND: To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy for patients with MDD. METHODS: Multicenter, double-blind, randomized, parallel-group, placebo-controlled study (D1448C00003) of quetiapine XR monotherapy. Eligible patients (HAM-D total score ≥22, item 1 score ≥2) received quetiapine XR 150mg/day for 8 weeks; in patients with an inadequate response (failure to achieve ≥20% improvement in MADRS) at Week 2 the dose was adjusted to 300mg/day for final 6 weeks. Primary endpoint: change from randomization to Week 8 in MADRS total score. Secondary endpoints included: MADRS response (≥50% reduction in total score from randomization); changes from randomization to Week 8 in HAM-D and CGI-S. Adverse events (AEs) were recorded throughout the study. RESULTS: 310 patients were randomized to double-blind treatment: 154 quetiapine XR, 156 placebo. At Week 8, quetiapine XR significantly reduced mean MADRS score versus placebo (-16.49 vs -13.10, respectively; p<0.01). At Week 1 (Day 8) mean MADRS score was significantly reduced by quetiapine XR versus placebo (p<0.05). MADRS response rates were significantly greater at Week 8 for quetiapine XR versus placebo (61.9% versus 48.0%, respectively; p<0.05). Change in HAM-D total score at Week 8 was -14.75 quetiapine XR versus -12.35 placebo (p<0.05). Change in CGI-S score at Week 8 was -1.64 quetiapine XR versus -1.24 placebo (p<0.01). Most common AEs (>10% any group) were dry mouth, sedation, somnolence and headache. CONCLUSIONS: In patients with MDD, quetiapine XR monotherapy is effective and generally well tolerated with symptom improvement seen as early as Week 1. Supported by Research sponsored by AstraZeneca