title: Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder.
abstract: The aim of this post-hoc analysis was to determine whether early symptom improvement with extended release quetiapine (quetiapine XR) may predict treatment outcome in patients with major depressive disorder. Data were from 6, double-blind, placebo-controlled studies of quetiapine XR (2 fixed-dose and 2 flexible-dose monotherapy and 2 adjunct studies) in adult patients with major depressive disorder. Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity Score (CGI-S) were assessed at baseline, weeks 2, 4, and 6. Hamilton Rating Scale for Depression (HAM-D) was assessed at baseline and week 6. The MADRS improvement at week 2 (15%, 20%, 25%, 30%) was used to predict response and remission, based on MADRS (50% improvement; total score ≤ 12) or HAM-D (50% improvement; total score ≤ 7). The CGI-S improvement (1 point) at week 2 was used to predict final outcome (CGI-S score ≤ 2). The predictive value for early improvement with quetiapine XR was found to be "very strong" (Yule's Q coefficient, a combined measure of sensitivity and specificity) using 30% MADRS improvement as the threshold. This was relatively comparable for response and remission and for fixed-dose, flexible-dose, and adjunct studies. This was also observed for placebo. Exceptions were: adjunct studies (where predictivity was lower for ongoing antidepressant/placebo), and for remission (predictivity for remission appeared lower than for response with placebo). In conclusion, outcome at week 6 with quetiapine XR for a major depressive episode could be predicted by 30% improvement after 2 weeks, a finding that could give doctors confidence to continue treatment and may facilitate adherence in patients.
authors.affiliation: From the *Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada; †Centre de Psychiatrie et Neurosciences (INSERM U894) Paris-Descartes University, Sainte-Anne Hospital (CMME), Paris, France; ‡Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA; §AstraZeneca Pharmaceuticals, Wilmington, DE; and ∥University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: Roger S
authors.initials: RS
authors.lastname: McIntyre
authors.forename: Philip
authors.initials: P
authors.lastname: Gorwood
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.forename: Charlie
authors.initials: C
authors.lastname: Liss
authors.forename: Dhaval
authors.initials: D
authors.lastname: Desai
authors.forename: Ji
authors.initials: J
authors.lastname: Chen
authors.forename: Michael
authors.initials: M
authors.lastname: Bauer
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D017063:Outcome Assessment, Health Care; D000069348:Quetiapine Fumarate / Q000008:administration & dosage / Q000494:pharmacology*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000069348:Quetiapine Fumarate