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P0056 - Reduction of anxiety symptoms in patients with major depressive disorder treated with Desvenlafaxine Succinate: A pooled analysis

Published online by Cambridge University Press:  16 April 2020

K.A. Tourian
Affiliation:
Department of Clinical Research/Development and Neuroscience, Wyeth Research, Collegeville, PA, USA
S. Ahmed
Affiliation:
Department of Global Medical Affairs, Wyeth Research, Collegeville, PA, USA
A. Patroneva
Affiliation:
Department of Global Medical Affairs, Wyeth Research, Collegeville, PA, USA
B. Zitek
Affiliation:
Department of Global Medical Affairs, Wyeth Research, Collegeville, PA, USA
J. Graepel
Affiliation:
Department of Postmarketing Biostatistics, Wyeth Research, Collegeville, PA, USA
B. Pitrosky
Affiliation:
Department of Neuroscience, Wyeth Research, Paris, France

Abstract

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Objective:

To assess the efficacy of desvenlafaxine succinate (DVS) treatment in reducing symptoms of anxiety in patients with major depressive disorder (MDD).

Methods:

Data were pooled from 7 randomized, double-blind, placebo-controlled, 8-week DVS trials. All studies enrolled adult outpatients with DSM-IV MDD. Patients were excluded if an anxiety disorder was the primary diagnosis. Eligible patients were randomly assigned to treatment with 100–400 mg/d DVS (n=1186) or placebo (n=797) for 8 weeks. The primary efficacy outcomes in this analysis were the 17-item Hamilton Rating Scale for Depression (HAM-D17) item 10 (Anxiety/Psychic) and the Covi Anxiety total score (measured in 6 of the 7 trials). Patients with a Covi Anxiety score >9 or whose Covi score exceeded their Raskin Depression total score were not enrolled. Changes from baseline were analyzed using a mixed-effects model for repeated measures (MMRM) analysis, which included the fixed, categorical effects of treatment, protocol, visit, and the treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. Secondary analyses evaluated changes from baseline to end point using analysis of covariance (ANCOVA, using last-observation-carried-forward [LOCF] and observed cases [OC] analyses).

Results:

Improvement from baseline at week 8, the study end point, was significantly greater for the DVS group than for the placebo group on both the HAM-D17 Anxiety/Psychic item and Covi Anxiety total scores in both the MMRM and ANCOVA (LOCF and OC) analyses.

Conclusion:

In this pooled analysis, DVS was significantly superior to placebo in the treatment of anxiety symptoms associated with depression.

Type
Poster Session II: Antidepressants
Copyright
Copyright © European Psychiatric Association 2008
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