Published online by Cambridge University Press: 10 August 2012
This study investigated the safety and efficacy of long-term treatment with high-dose desvenlafaxine (administered as desvenlafaxine succinate) in major depressive disorder (MDD).
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.
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.
High-dose desvenlafaxine (200–400 mg/d) was generally safe and effective in the long-term treatment of MDD.
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.