Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder.

Abstract: Background: Major depressive disorder (MDD) is frequently associated with reduced quality of life (QoL) and sleep disturbance. We investigated the effects of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy on QoL and sleep in elderly patients with MDD. Methods: Prospectively planned analysis of patient-reported data from an 11-week (9-week randomized; 2-week post-treatment), double-blind, placebo-controlled, Phase III study. Elderly patients (≥66 years; DSM-IV MDD; Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 score ≥2) were randomized to quetiapine XR (flexible dosing 50–300mg/day) or placebo. Primary outcome: MADRS total score change from randomization at Week 9. Patient-reported outcomes: Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) % of maximum total score (Items 1–14), Q-LES-Q-SF Item 15 (‘satisfaction with medication’), Q-LES-Q-SF Item 16 (‘overall life satisfaction’), and Pittsburgh Sleep Quality Index (PSQI) global score. Results: In total, 338 patients were randomized (166 quetiapine XR; 172 placebo). At Week 9, quetiapine XR significantly reduced MADRS total score (−16.33; difference: −7.54; 95% CI: −9.23, −5.85; p<0.001) versus placebo (−8.79). Quetiapine XR significantly improved Q-LES-Q-SF % of maximum total score (16.86; difference: 7.69; 95% CI: 4.99, 10.39; p<0.001) versus placebo (9.17), with numerical improvement in Q-LES-Q-SF Item 15 and improvement in Item 16. Improvement in PSQI global score was observed with quetiapine XR (-6.42; difference: −3.52; 95% CI: −4.26, −2.79; p<0.001) versus placebo (−2.89). Limitations: Lack of active-comparator arm, flexible-dose design, acute treatment period. Conclusions: Quetiapine XR monotherapy improved QoL and sleep in elderly patients with MDD. [Copyright &y& Elsevier]