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PW01-24 - Evaluation of the Effects of Quetiapine XR Monotherapy According to MDD Severity: Pooled Data From 4 Placebo-controlled Trials

Published online by Cambridge University Press:  17 April 2020

S. Montgomery ,
M. Thase ,
G. Papakostas ,
M. Bauer ,
M. Trivedi ,
H. Svedsäter ,
M. Udd ,
U. Gustafsson  and
H. Eriksson
S. Montgomery
Affiliation:
Imperial College School of Medicine, University of London, London, UK
M. Thase
Affiliation:
Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA
G. Papakostas
Affiliation:
Associate Professor of Psychiatry, Harvard Medical School, USA Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
M. Bauer
Affiliation:
Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Dresden, Germany
M. Trivedi
Affiliation:
Department of Psychiatry, UT Southwestern Medical Center-Dallas, Dallas, TX, USA
H. Svedsäter
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
M. Udd
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
U. Gustafsson
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
H. Eriksson
Affiliation:
AstraZeneca R&D, Södertälje, Sweden

Abstract

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Objectives

Evaluate the effects of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder (MDD) according to disease severity.

Methods

Pooled data (quetiapine XR 50, 150 and 300mg/day doses combined) from four 6- or 8-week placebo-controlled quetiapine XR monotherapy studies (D1448C00001, D1448C00002, D1448C00003, D1448C00004) were analysed. Key inclusion criterion for all 4 studies: HAM-D total score ≥22. Primary endpoint: change from randomisation in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. A post-hoc analysis assessed change from randomisation in MADRS total score and MADRS response (≥ 50% reduction in MADRS total score) at endpoint (Week 6 or Week 8) in 6 severity cohorts (defined by a MADRS total score at randomisation ≥24, ≥26, ≥28, ≥30, ≥32 or ≥34).

Results

1752 patients (comprising the l’ all patients’ group) were evaluated (MADRS score ≥24 at randomisation, n=1601; ≥26, n=1467; ≥28, n=1269; ≥30, n=1038; ≥32, n=745; ≥34, n=500). Quetiapine XR significantly reduced mean MADRS total score at endpoint in lrsquo;all patients’ (p< 0.001 vs placebo) and in all 6 severity cohorts (≥24, ≥26, ≥28, ≥30 and ≥32, p< 0.001 vs placebo; ≥34, p< 0.01 vs placebo). MADRS response rates were significantly higher in the quetiapine XR group vs placebo in the ‘all patients’ group (p< 0.001 vs placebo) and in all 6 severity cohorts (≥24, ≥26, ≥28, ≥30 and ≥32, p< 0.001 vs placebo; ≥34, p=0.001 vs placebo).

Conclusions

Quetiapine XR monotherapy significantly improved depressive symptoms in patients with MDD irrespective of disease severity, including the most severe levels of depression.

AstraZeneca funded

Type
Affective disorders / Unipolar depression / Bipolar disorder
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E1426
Copyright
Copyright © European Psychiatric Association 2010
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