Extended release quetiapine fumarate as adjunct to antidepressant therapy in patients with major depressive disorder: pooled analyses of data in patients with anxious depression versus low levels of anxiety at baseline

Abstract

Objectives. To evaluate quetiapine XR in patients with anxious depression, as defined by HAM-A total and HAM-D anxiety/somatisation factor scores. Methods. Post hoc analyses of pooled data from two 6-week, double-blind, randomised, placebo-controlled studies of adjunctive quetiapine XR (150 or 300 mg/day) in patients with MDD and inadequate response to antidepressants. Patients were stratified in a primary analysis using HAM-A (HAM-A total score at baseline ≥ 20 [“high”] or < 20 [“low”]) and a secondary analysis using HAM-D (anxious depression defined as HAM-D anxiety/somatisation factor score ≥ 7). Outcomes included change in MADRS total score. Results. In patients with high anxiety levels (HAM-A total score ≥ 20), reductions in MADRS total score were –15.20 (P = 0.122) and –15.92 (P < 0.05) for quetiapine XR 150 and 300 mg/day, respectively, vs. placebo (–13.49). In patients with low levels of anxiety (HAM-A total score < 20), both quetiapine XR doses (P < 0.001) improved MADRS total scores vs. placebo. In the secondary analysis, quetiapine XR 150 (P < 0.01) and 300 mg/day (P < 0.001) improved MADRS total score vs. placebo in patients with HAM-D anxiety/somatisation factor score ≥ 7. Conclusions. Adjunct quetiapine XR demonstrates efficacy in patients with anxious and non-anxious depression, assessed using HAM-A total score, and anxious depression assessed using HAM-D anxiety/somatisation factor score.

Key words::

• adjunct therapy
• anxious depression
• atypical antipsychotic
• extended-release quetiapine fumarate
• major depressive disorder

Acknowledgements

These studies (D1448C00006 [Pearl]; D1448C00007 [Onyx]) were funded by AstraZeneca. The studies were both registered at ClinicalTrials.gov (D1448C00006 study identifier number NCT00326105; D1448C00007 study identifier number NCT00351910). We thank Varinia Munoz, PhD, from Complete Medical Communications, who provided medical writing support funded by AstraZeneca.

Statement of Interest

Borwin Bandelow has received consulting fees or honoraria within the past 3 years from: AstraZeneca, GlaxoSmithKline, Janssen, Lilly, Lundbeck, Otsuka, Pfizer and Servier.

Michael Bauer has received grant/research support from The Stanley Medical Research Institute, NARSAD, Deutsche Forschungsgemeinschaft, European Commission (FP7), American Foundation for Suicide Prevention and Bundesministerium für Bildung und Forschung (BMBF). He is a consultant for Alkermes, AstraZeneca, Bristol-Myers Squibb, Ferrer Internacional, Janssen, Lilly, Lundbeck, Otsuka, Servier, Takeda, and has received speaker honoraria from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Lundbeck, Otsuka and Pfizer.

Eduard Vieta has acted as a consultant or received grants or honoraria for lectures from: Adamed, Almirall, AstraZeneca, Bial, Bristol-Myers Squibb, Cephalon, Forest Research Institute, Gedeon Richter, GlaxoSmithKline, Janssen, Jazz, Johnson & Johnson, Lilly, Lundbeck, Merck Sharp & Dohme, Novartis, Organon, Otsuka, Pfizer, Pierre Fabre, sanofi-aventis, Schering Plough, Servier, Takeda, UBC and Wyeth.

Nizar El-Khalili has received research grants from, or has participated in advisory boards or speakers’ bureaux for: AstraZeneca, GlaxoSmithKline, Lilly, Pfizer and sanofi-aventis.

Urban Gustafsson and Hans Eriksson are former employees of AstraZeneca R&D, Södertälje, Sweden.

Willie R. Earley is a former employee of AstraZeneca R&D, Wilmington, DE, USA.