title: Analysis of potentially predictive factors of efficacy of adjunct extended-release quetiapine fumarate in patients with major depressive disorder.
abstract: Identification of predictors of treatment response in patients with major depressive disorder (MDD) may facilitate improved disease management. Data were pooled from two 6-week, double-blind, placebo-controlled studies of extended-release quetiapine (quetiapine XR; 150 or 300 mg/day) as adjunct to ongoing antidepressant therapy. Effects of psychiatric history and baseline demographic and disease characteristics on efficacy outcomes (Week 6 Montgomery Åsberg Depression Rating Scale [MADRS] total score reduction) were evaluated in population subgroups (quetiapine XR both doses pooled, n = 616; placebo, n = 303). Baseline Clinical Global Impressions-Severity (CGI-S) score and previous depressive episodes on Week 6 MADRS total score change, and baseline MADRS individual item scores on Week 6 change in CGI-Improvement score, were also evaluated. No major differences between responders and non-responders to quetiapine XR were observed for patient characteristics or demographic and disease characteristics. No suggestion of a predictive association was found between baseline CGI-S score, number of depressive episodes, and baseline MADRS item scores and efficacy outcomes. These analyses showed no major differences between responders and non-responders, and no predictive association between the parameters assessed and efficacy outcomes for adjunct quetiapine XR in patients with MDD and an inadequate response to prior antidepressant therapy.
authors.affiliation: University Hospital Carl Gustav Carus, Dresden, Germany michael.bauer@uniklinikum-dresden.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Bauer
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.affiliation: AstraZeneca Pharmaceuticals, Wilmington, DE, USA.
authors.forename: Sherry
authors.initials: S
authors.lastname: Liu
authors.affiliation: Former-AstraZeneca Pharmaceuticals, Wilmington, DE, USA.
authors.forename: Willie
authors.initials: W
authors.lastname: Earley
authors.affiliation: Former-AstraZeneca R&D, Södertälje, Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000069348:Quetiapine Fumarate
keywords: Adjunct; atypical antipsychotic; extended-release quetiapine fumarate; major depressive disorder; predictive factors