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PW01-03 - Evaluation of the Effects of Quetiapine XR Monotherapy On Sleep Disturbance In Patients With MDD

Published online by Cambridge University Press:  17 April 2020

B. Bandelow
Affiliation:
Department of Psychiatry and Psychotherapy, University of Goettingen, Goettingen, Germany
K. Demyttenaere
Affiliation:
University Hospital Gathuisburg, Leuven, Belgium
G. Papakostas
Affiliation:
Psychiatry, Harvard Medical School, Boston, MA, USA Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
M. Trivedi
Affiliation:
Department of Psychiatry, UT Southwestern Medical Center-Dallas, Dallas, TX, USA
J. Szamosi
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
W. Earley
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA
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 on sleep disturbance in patients with major depressive disorder (MDD).

Methods

Pooled data from four 6- or 8-week placebo-controlled quetiapine XR (50-300mg/day, administered in the evening) monotherapy studies (D1448C00001, D1448C00002, D1448C00003, D1448C00004) were analysed. Primary endpoint: change from randomisation in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Post-hoc analyses assessed changes in: MADRS item 4 (reduced sleep); Hamilton Rating Scale for Depression (HAM-D) items 4 (insomnia-early), 5 (insomnia-middle) and 6 (insomnia-late) and sleep disturbance factor (items 4+5+6); Pittsburgh Sleep Quality Index (PSQI) total and item scores. MADRS total score change was analysed for patients experiencing high (baseline HAM-D sleep disturbance factor score >=4) and low (baseline HAM-D sleep disturbance factor score < 4) sleep disturbance.

Results

In total, 2,116 patients were randomised. At last assessment, quetiapine XR (all doses combined) significantly (p< 0.001) reduced MADRS item 4, HAM-D sleep disturbance factor and items 4, 5 and 6 and PSQI total scores from baseline versus placebo. Quetiapine XR significantly (p< 0.001) improved MADRS total score from baseline versus placebo at all time points in patients experiencing high sleep disturbance (n=865, quetiapine XR; n=514, placebo). Quetiapine XR improved MADRS total score versus placebo in patients with low sleep disturbance (n=252, quetiapine; n=121, placebo): difference significant at Weeks 2(p< 0.001), 4(p< 0.05) and 6(p< 0.05).

Conclusions

Quetiapine XR monotherapy improved symptoms of sleep disturbance in MDD and was effective against depressive symptoms in patients experiencing high and low sleep disturbance levels. AstraZeneca funded.

Type
Affective disorders / Unipolar depression / Bipolar disorder
Copyright
Copyright © European Psychiatric Association 2010
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