Desvenlafaxine and weight change in major depressive disorder.
OBJECTIVE
To characterize weight change during short- and longer-term treatment with desvenlafaxine (administered as desvenlafaxine succinate) for major depressive disorder (MDD).


METHODS
Data from 9 short-term, double-blind, placebo-controlled studies and 1 longer-term relapse-prevention trial conducted between September 2002 and January 2007 were analyzed. Adult outpatients with a primary diagnosis of MDD using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition received fixed- or flexible-dose desvenlafaxine or placebo for 8 weeks in the short-term studies. In the longer-term study, responders to 12 weeks of open-label desvenlafaxine treatment were randomly assigned to double-blind treatment with desvenlafaxine or placebo for 6 months. Mean weight changes and incidence of potentially clinically important changes were evaluated.


RESULTS
In the short-term studies (desvenlafaxine: n = 1,834; placebo: n = 1,116), mean decreases in weight associated with desvenlafaxine were small but statistically significant compared with baseline (P < .05) and with placebo (final evaluation: -0.82 kg desvenlafaxine vs + 0.05 kg placebo; P < .001). Likewise, during the 12-week, open-label phase of the relapse-prevention study (n = 594), a small but statistically significant mean decrease in weight from baseline (-0.8 kg; P < .001) occurred. Small mean increases in weight (< 1 kg) were observed with both desvenlafaxine (n = 190) and placebo (n = 185) throughout the relapse-prevention phase, with no statistical difference between desvenlafaxine- and placebo-treated patients at the final evaluation. Less than 1% of desvenlafaxine-treated patients experienced a clinically meaningful weight change.


CONCLUSIONS
Desvenlafaxine was not associated with clinically significant weight change during short- or longer-term treatment.
Tourian
Karen A
KA
Wyeth Research, Collegeville, Pennsylvania ; and Wyeth Research, Paris, France . Drs Tourian and Leurent are currently with Wyeth, a company of the Pfizer Group, Paris, France, and Drs Graepel and Ninan are currently with Pfizer Inc, Collegeville, Pennsylvania.
Leurent
Claire
C
Graepel
Jay
J
Ninan
Philip T
PT