Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study.

Objective: This 6-week, randomized, double-blind study evaluated efficacy and safety of adjunctive extended-release (XR) quetiapine in patients with major depressive disorder (MDD) and an inadequate response to >or= 1 antidepressant. Methods: Male or female patients aged 18 to 65 years with DSM-IV-TR MDD were randomly assigned to receive quetiapine XR (150 or 300 mg/day) or placebo adjunctive to continuing antidepressant. Primary endpoint was change from randomization to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Secondary variables included MADRS response (>or= 50% reduction in score from randomization) at weeks 1 and 6, MADRS remission (

Background: clinicaltrials.gov Identifier: NCT00351910.