Desvenlafaxine for the prevention of relapse in major depressive disorder:
results of a randomized trial.
Author(s): Rickels K, Montgomery SA, Tourian KA, Guelfi JD, Pitrosky B, Padmanabhan SK,
Germain JM, Leurent C, Brisard C.
Affiliation(s): Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104,
USA. Krickels@mail.med.upenn.edu
Publication date & source: 2010, J Clin Psychopharmacol. , 30(1):18-24
OBJECTIVES: To compare the efficacy and safety of desvenlafaxine (administered as
desvenlafaxine succinate) with placebo in reducing relapse rate in patients with
major depressive disorder (MDD).
METHODS: This phase 3, multicenter, randomized trial included a 12-week,
open-label (OL) treatment phase (intent-to-treat population, n = 575) followed by
a 6-month, double-blind (DB) relapse prevention phase. Patients who responded to
the OL treatment (17-item Hamilton Rating Scale for Depression total score or= 16 at any visit, Clinical Global
Impression-Improvement score >or= 6 at any visit, or discontinuation due to
unsatisfactory response).
RESULTS: Patients receiving desvenlafaxine (n = 189) experienced significantly
longer times to relapse of MDD versus patients receiving placebo (n = 185) during
the DB period (log-rank test, P < 0.0001). The percentages of patients relapsing
were 42% (78/185) and 24% (45/189) for placebo and desvenlafaxine, respectively
(P < 0.001). The most common primary reason cited for discontinuation in the OL
period was adverse events (19%), which consisted of nausea, dizziness, and
insomnia. A total of 159 patients (42%) discontinued treatment during the DB
period, including 101 placebo- (55%) and 58 desvenlafaxine-treated patients
(31%). The most frequent adverse event reported as reason for treatment
discontinuation in the DB period was depression, reported by 14 placebo- (8%) and
7 desvenlafaxine-treated patients (4%).
CONCLUSIONS: Desvenlafaxine effectively prevented relapse of MDD during 6 months
of DB treatment in patients who had responded to 12 weeks of OL desvenlafaxine
therapy.
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