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Adjunct quetiapine xr in patients with major depressive disorder: a pooled analysis of data from patients with anxious depression

Published online by Cambridge University Press:  16 April 2020

B. Bandelow
Affiliation:
Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany
E. Vieta
Affiliation:
Bipolar Disorders Program, Hospital Clinic, University of Barcelona, IDIBAPS, CIBER-SAM, Barcelona, Spain
N. El-Khalili
Affiliation:
Alpine Clinic, Lafayette, IN, USA
M. Bauer
Affiliation:
Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Dresden, Germany
S. Nyberg
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
H. Eriksson
Affiliation:
AstraZeneca R&D, Södertälje, Sweden

Abstract

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Objective

This pooled analysis evaluated efficacy of adjunct quetiapine XR (QTP-XR) in subgroups of patients with anxious depression and lower levels of anxiety.

Methods

Pooled data from two 6-week, double-blind, randomised, placebo-controlled trials (D1448C00006/D1448C00007) in patients with inadequate response to antidepressants were analysed. Patients received adjunct QTP-XR (150 or 300 mg/day) or placebo+antidepressant (SSRI or SNRI). Using criteria defined in the STAR*D study, analyses conducted in patients with anxious depression or lower baseline anxiety levels (HAM-D anxiety/somatic factor score >/ = 7 and < 7, respectively) included LSM change at Week 6 in: MADRS total (primary endpoint), HAM-A and CGI-S total scores.

Results

For patients with anxious depression (n = 697; 76% patients), adjunct QTP-XR 150mg/day (-14.44, p < 0.01) and 300 mg/day (-15.09, p < 0.001) significantly improved MADRS total scores versus placebo+antidepressant (-11.78) at Week 6, with significant improvement demonstrated from Week 1 onwards. Significant improvements were seen in HAM-A (QTP-XR 150 mg/day: -9.05, p < 0.01; 300 mg/day -9.43, p < 0.01) and CGI-S total scores (QTP-XR 150 mg/day: -1.60, p< 0.001; 300 mg/day -1.63, p < 0.001) versus placebo+antidepressant (-7.40, -1.22, respectively) at Week 6.

A smaller subgroup (n = 222; 24% patients) had lower baseline anxiety levels. At Week 1, adjunct QTP-XR (150 mg/day -9.09; p < 0.01; 300 mg/day -8.60; p < 0.05) significantly improved MADRS total score versus placebo+antidepressant (-5.93). At Week 6 there were no significant changes (QTP-XR 150 mg/day -14.49; p = 0.243; 300 mg/day -14.01; p = 0.388) versus placebo+antidepressant (-12.78).

Conclusions

For patients with anxious depression, adjunct QTP-XR (150 and 300 mg/day) was effective at reducing symptoms of anxiety and depression, with symptom improvement observed from Week 1 onwards. AstraZeneca funded.

Type
P02-11
Copyright
Copyright © European Psychiatric Association 2011
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