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High-dose desvenlafaxine in outpatients with major depressive disorder

Published online by Cambridge University Press:  10 August 2012

James M. Ferguson ,
Karen A. Tourian  and
Gregory R. Rosas
James M. Ferguson*
Affiliation:
University of Utah School of Medicine, Salt Lake City, Utah, USA
Karen A. Tourian
Affiliation:
Wyeth Research, A Company of the Pfizer Group, Paris, France
Gregory R. Rosas
Affiliation:
Pfizer Inc., formerly Wyeth Research, Collegeville, Pennsylvania, USA
*
*Address for correspondence: James Ferguson, MD, Clinical Professor, Psychiatry, University of Utah School of Medicine, 1611 Federal Heights Drive, Salt Lake City, UT 84103, USA. (Email [email protected])
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Abstract

Objective

This study investigated the safety and efficacy of long-term treatment with high-dose desvenlafaxine (administered as desvenlafaxine succinate) in major depressive disorder (MDD).

Methods

In this multicenter, open-label study, adult outpatients with MDD aged 18–75 were treated with flexible doses of desvenlafaxine (200–400 mg/d) for ≤ 1 year. Safety assessments included monitoring of treatment-emergent adverse events (TEAEs), patient discontinuations due to adverse events, electrocardiograms, vital signs, and laboratory determinations. The primary efficacy measure was mean change from baseline in the 17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score.

Results

The mean daily desvenlafaxine dose range over the duration of the trial was 267–356 mg (after titration). The most frequent TEAEs in the safety population (n = 104) were nausea (52%) and headache (41%), dizziness (31%), insomnia (29%), and dry mouth (27%). All TEAEs were mild or moderate in severity. Thirty-four (33%) patients discontinued from the study because of TEAEs; nausea (12%) and dizziness (9%) were the most frequently cited reasons. The mean change in HAM-D(17) total score for the intent-to-treat population (n = 99) was −9.9 at the last on-therapy visit in the last-observation-carried-forward analysis and −14.0 at month 12 in the observed cases analysis.

Conclusion

High-dose desvenlafaxine (200–400 mg/d) was generally safe and effective in the long-term treatment of MDD.

Keywords

Depressiondesvenlafaxineoutpatients
Type
Original Research
Information
CNS Spectrums , Volume 17 , Issue 3 , September 2012 , pp. 121 - 130
Copyright
Copyright © Cambridge University Press 2012

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Footnotes

This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc. in October 2009. The authors wish to thank S. Krishna Padmanabhan of Pfizer (formerly Wyeth) for statistical support in connection with the study and manuscript development. We also thank Susan M. Adamczyk, MS, of On Assignment for her professional medical writing and editorial assistance, which was funded by Wyeth. Additional medical writing support for this manuscript was provided by Carol Grimes, PhD, at Embryon, LLC, a division of Advanced Health Media, LLC, and Lorraine Sweeney, BA, at Embryon and Peloton Advantage LLC, and was funded by Pfizer Inc.

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