Extended Release Quetiapine Fumarate Monotherapy for Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Study

Abstract

Introduction: Once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy was evaluated in major depressive disorder (MDD).Method: This was an 8-week (6-week randomized-phase; 2-week drug-discontinuation/tapering phase), double-blind, parallel-group, placebo-controlled study. The primary outcome measure was Montgomery-Åsberg Depression Rating Scale (MADRS) total score randomization-to-Week 6 change. Other assessments included the Hamilton Rating Scale for Depression, the Hamilton Rating Scale for Anxiety, and adverse events (AEs).Results: 723 patients were randomized: 182, 178, 179, and 184 to quetiapine XR 50, 150, 300 mg/day, and placebo, respectively. At Week 6, significant reductions occurred in MADRS score with quetiapine XR 50 mg/day (−13.56; P<.05), 150 mg/day (−14.50; P<.01) and 300 mg/day (−14.18; P<.01) versus placebo (−11.07); at Day 4, reductions for quetiapine XR (titrated to 50 or 150 mg/day according to dose group) versus placebo (−2.9) were: −4.7 (P<.01), −5.2 (P<.001), and −5.1 (P<.001), respectively. At endpoint, MADRS response (≥50% reduction in score) was 42.7% (P<.01), 51.2% (P<.001), and 44.9% (P≤.001) for quetiapine XR 50, 150, and 300 mg/day, respectively; 30.3% for placebo. Overall, quetiapine XR 150 mg/day provided consistently more positive secondary efficacy results than 50 mg/day and 300 mg/day versus placebo. The most common AEs in quetiapine XR-treated patients were dry mouth, sedation, somnolence, headache, and dizziness.Conclusion: In patients with MDD, quetiapine XR monotherapy (50/150/300 mg/day) is effective in reducing depressive symptoms, with improvement from Day 4 onwards. Safety and tolerability were consistent with the known profile of quetiapine.

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

“…In contrast to the current study of youth with bipolar depression, quetiapine XR has demonstrated efficacy in the acute treatment of adults with bipolar depression or MDD (Weisler et al 2009;Bauer et al 2010;Suppes et al 2010). In particular, an 8-week, placebocontrolled study of adults with bipolar depression showed significant efficacy for quetiapine XR (300 mg/day) versus placebo, measured by Montgomery-Asberg Depression Rating Scale (MADRS) score, with divergence from the first week of treatment (Suppes et al 2010).…”

“…Quetiapine XR, in addition to efficacy as monotherapy in adults with schizophrenia, bipolar mania, and bipolar depression, has efficacy as monotherapy in adults with generalized anxiety disorder and as both monotherapy and adjunctive therapy in adults with major depressive disorder (MDD) (Kahn et al 2007;Weisler et al 2009;Bandelow et al 2010;Bauer et al 2010;Suppes et al 2010;Cutler et al 2011).…”

462 – Quetiapine monotherapy in acute phase for major depressive disorder: a metaanalysis of randomized, placebo-controlled trials

“…By reviewing the titles and abstracts, 136 trials were excluded since they clearly did not meet the criteria. Full papers of five studies were examined [30][31][32][33]39], two studies were excluded since one was a study of maintenance treatment [30] and the other studied in geriatric patients [39], only three trials [31][32][33], therefore, were included in the review. No relevant, unpublished study meeting the inclusion criteria was identified.…”

“…Recently, some randomized-controlled trials of quetiapine have been conducted in patients with MDD [30][31][32][33]. Since most of these studies have small samples, a meta-analysis, which is more powerful in estimating the true effect size, may be a strategy to confirm its efficacy and safety.…”

Depression and schizophrenia

“…Notably, quetiapine (Calabrese 2005;Thase 2006;Suppes 2009) and olanzapine (Tohen 2003;Vieta 2010) have been successful for bipolar depression, while for major depressive disorder, quetiapine has been efficacious as a solo agent (Cutler 2009;McIntyre 2009;Weisler 2009) and as an adjunct to anti depressants (Dannlowski 2008), as has aripiprazole as an adjunct in major depressive disorder (Papakostas 2005;Patkar 2006;Rutherford 2007;Schwartz 2007;Arbaizar 2009;Berman 2009;Steffens 2011) and bipolar disorder (Kemp 2007;Sokolski 2007;Arbaizar 2009). But such assumptions might not be supportable, given the complexity of schizophrenia, including its differential and multifactorial aetiology and epiphenomena.…”