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

Abstract

BackgroundMajor 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. MethodsProspectively 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. ResultsIn 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). LimitationsLack of active-comparator arm, flexible-dose design, acute treatment period. ConclusionsQuetiapine XR monotherapy improved QoL and sleep in elderly patients with MDD.