title: Efficacy of extended release quetiapine fumarate monotherapy in elderly patients with major depressive disorder: secondary analyses in subgroups of patients according to baseline anxiety, sleep disturbance, and pain levels.
abstract: This study evaluated extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder (MDD) according to baseline levels of anxiety, sleep disturbance, and pain. Post-hoc analyses of data from an 11-week (9-week randomized-treatment, 2-week post-treatment phase), double-blind, placebo-controlled study of quetiapine XR (50-300 mg/day) monotherapy in elderly (≥66 years) patients (n=338) with MDD were carried out. Outcomes included randomization to week 9 change in Montgomery Åsberg Depression Rating Scale (MADRS) score and week 9 response (≥50% MADRS score reduction) rates. Post-hoc analyses were carried out to assess subgroups of patients with MDD according to baseline levels in terms of the following: higher or lower anxiety (Hamilton Rating Scale for Anxiety total score≥20 or < 20, respectively); high or low sleep disturbance [Hamilton Rating Scale for Depression sleep disturbance factor (items 4+5+6) score≥5 or <5, respectively]; and pain visual analog scale total score 40 mm or higher or less than 40 mm. At week 9, quetiapine XR reduced the MADRS total score compared with placebo in the higher anxiety (least squares mean change -17.8 vs. -8.5; P<0.001) and lower anxiety (-14.8 vs. -8.8; P<0.001) subgroups. MADRS total score was also reduced with quetiapine XR compared with placebo in the high (-17.6 vs. -8.7; P<0.001) and low (-14.4 vs. -9.2; P<0.001) sleep disturbance subgroups, as well as in the pain visual analog scale subgroups [≥40 mm (-16.6 vs. -8.9; P<0.001) and <40 mm (-15.7 vs. -8.7; P<0.001)]. Quetiapine XR response rates were higher than those of placebo in all subgroups analyzed. In this study, quetiapine XR (50-300 mg/day) monotherapy was shown to be effective against depressive symptoms in elderly patients with MDD, irrespective of baseline levels of anxiety, sleep disturbance, and pain.
authors.affiliation: aEmeritus Professor of Psychiatry, Imperial College, University of London, London, UK bDepartment of Psychiatry, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy cDepartment of Psychiatry, Helsinki University Central Hospital, Helsinki, Finland dAstraZeneca Pharmaceuticals, Wilmington, Delaware, USA eFormerly AstraZeneca R&D, Södertälje, Sweden.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Montgomery
authors.forename: A Carlo
authors.initials: AC
authors.lastname: Altamura
authors.forename: Heikki
authors.initials: H
authors.lastname: Katila
authors.forename: Catherine
authors.initials: C
authors.lastname: Datto
authors.forename: Johan
authors.initials: J
authors.lastname: Szamosi
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
mesh_terms: D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D003987:Dibenzothiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010146:Pain / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy* / Q000523:psychology
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate