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P0067 - Once-daily extended-release Quetiapine Fumarate (Quetiapine XR) monotherapy in generalised anxiety disorder (GAD): A placebo-controlled study with active-comparator Patoxetine

Published online by Cambridge University Press:  16 April 2020

G. Chouinard ,
J. Bobes ,
A. Ahokas ,
I. Eggens ,
S. Liu  and
M. Brecher
G. Chouinard
Affiliation:
Clinical Psychopharmacolgy Unit, McGill University, Montreal, QC, Canada
J. Bobes
Affiliation:
Department of Psychiatry, University of Oviedo, Asturias, Spain
A. Ahokas
Affiliation:
Mehilainen Clinic, Runberginkatu 47A, Helsinki, Finland
I. Eggens
Affiliation:
AstraZeneca R&D, Sodertalje, Sweden
S. Liu
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA
M. Brecher
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA

Abstract

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Objectives:

To evaluate the efficacy and tolerability of once-daily quetiapine XR monotherapy in outpatients with moderate-to-severe GAD without major depressive disorder.

Methods:

10-week (8-week active treatment, randomised phase; 2-week post-treatment drug-discontinuation/tapering phase), multicentre, double-blind, placebo-controlled, parallel-group comparison with paroxetine study (D1448C00011). 873 patients were randomised to receive quetiapine XR 50mg/day (n=221), 150mg/day (n=218), paroxetine 20mg/day (n=217) or placebo (n=217). Primary endpoint: change from baseline to Week 8 in HAM-A total score. Secondary outcomes included: change from baseline to Week 8 in HAM-A psychic and somatic clusters.

Results:

Mean HAM-A total score (overall baseline mean, 26.98) was significantly reduced at Week 8 by quetiapine XR 50mg/day (-13.95, p<0.05), 150mg/day (-15.96, p<0.001) and paroxetine (-14.45, p<0.01) versus placebo (-12.30).

At Week 8, mean HAM-A psychic cluster score (overall baseline mean, 14.40) was significantly reduced by quetiapine XR 50mg/day (-7.42, p<0.01), 150mg/day (-8.64, p<0.001) and paroxetine (-7.70, p<0.001) versus placebo (-6.27). Mean HAM-A somatic cluster score (overall baseline mean, 12.58) was significantly reduced by quetiapine XR 150mg/day (-7.37, p<0.001) versus placebo (-6.00), but not quetiapine XR 50mg/day (-6.54, p=0.15) or paroxetine (-6.74, p=0.05).

The incidence of serious AEs was low (<2%) in all treatment groups. During Weeks 1-8, most common AEs (>10%) were dry mouth, somnolence, fatigue, dizziness and headache with quetiapine; headache with placebo; and somnolence, dizziness, headache and nausea with paroxetine.

Conclusion:

Once-daily oral treatment with quetiapine XR (50 and 150mg/day) was well tolerated and significantly reduced anxiety symptoms, demonstrating effects on both somatic and psychic symptoms, in patients with GAD.

Type
Poster Session II: Anxiety Disorders
Information
European Psychiatry , Volume 23 , Issue S2: 16th AEP Congress - Abstract book - 16th AEP Congress , April 2008 , pp. S211
Copyright
Copyright © European Psychiatric Association 2008
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