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P0173 - Effect of once-daily extended release Quetiapine Fumarate (Quetiapine XR) as add-on to antidepressants in major depressive disorder (MDD)

Published online by Cambridge University Press:  16 April 2020

M. Bauer ,
H.W. Pretorius ,
W. Earley ,
P. Lindgren  and
M. Brecher
M. Bauer
Affiliation:
Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Dresden, Germany
H.W. Pretorius
Affiliation:
Department of Psychiatry, University of Pretoria & Weskoppies Hospital, Pretoria, South Africa
W. Earley
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA
P. Lindgren
Affiliation:
AstraZeneca R&D, Sodertalje, Sweden
M. Brecher
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA

Abstract

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Objective:

To evaluate the efficacy and tolerability of once-daily quetiapine XR adjunctive to antidepressant therapy versus antidepressant alone in patients with MDD showing an inadequate response to antidepressant treatment (mainly SSRIs/SNRIs).

Methods:

6-week, multicentre, double-blind, parallel-group study (D1448C00007). Patients were randomised to receive quetiapine XR 150mg/day (n=167), 300mg/day (n=163) or placebo (n=163) as add-on to maintained antidepressant treatment. Primary endpoint: baseline to Week 6 change in MADRS total score. Secondary variables included: baseline to Week 1 change in MADRS total score; baseline to Week 6 change in HAM-A total and psychic anxiety subscale scores. Safety assessments included AE reporting.

Results:

Mean change in MADRS total score (overall baseline mean, 28.4) from baseline to Week 6 was significant (p<0.01) for quetiapine XR 150mg/day (-15.26) and 300mg/day (-14.94) versus placebo (-12.21). Separation from placebo in MADRS total score was apparent from Week 1 for both quetiapine doses (p<0.001).

At Week 6, mean change from baseline in HAM-A total score (overall baseline mean, 20.8) was significant for quetiapine XR 150mg/day (-10.27, p<0.01) and 300mg/day (-9.70, p<0.05) versus placebo (-7.92). Mean change from baseline in HAM-A psychic anxiety subscale score (overall baseline mean, 12.83) was significant with quetiapine XR 150mg/day (-6.82, p<0.001) and 300mg/day (-6.47, p<0.01) versus placebo (-5.11).

Most common AEs (>10%) were dry mouth, somnolence, fatigue, sedation, constipation and dizziness with quetiapine XR.

Conclusion:

In patients with MDD with an inadequate response to antidepressant treatment, adjunctive quetiapine XR 150mg/day and 300mg/day was well tolerated and effective at reducing depressive and anxiety symptoms.

Type
Poster Session II: Depression
Information
European Psychiatry , Volume 23 , Issue S2: 16th AEP Congress - Abstract book - 16th AEP Congress , April 2008 , pp. S243
Copyright
Copyright © European Psychiatric Association 2008
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