Short-term efficacy and safety of desvenlafaxine in a randomized,
placebo-controlled study of perimenopausal and postmenopausal women with major
depressive disorder.
Author(s): Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ.
Affiliation(s): Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth
University, Richmond, VA 23209-0710, USA. skornstein@mcvh-vcu.edu
Publication date & source: 2010, J Clin Psychiatry. , 71(8):1088-96
BACKGROUND: The risk for major depressive disorder (MDD) increases during the
menopausal transition. Nonetheless, no large, placebo-controlled studies have
prospectively assessed the efficacy of antidepressants in perimenopausal or
postmenopausal women. This randomized, double-blind, placebo-controlled trial
evaluated the short-term efficacy and safety of desvenlafaxine (administered as
desvenlafaxine succinate) in perimenopausal and postmenopausal women with
DSM-IV-defined MDD.
METHOD: 387 depressed perimenopausal and postmenopausal women aged 40 to 70 years
were randomly assigned to placebo or desvenlafaxine (100 or 200 mg/d at the
discretion of the investigator) in an 8-week, flexible-dose trial conducted from
September 2006 to June 2008. The primary efficacy variable was change from
baseline in 17-item Hamilton Depression Rating Scale (HDRS(17)) total score,
analyzed using a mixed-effects model for repeated-measures analysis. Safety data
were collected throughout the trial.
RESULTS: The reduction in adjusted HDRS17 total scores from baseline to week 8
(mean daily dose after titration, 162 to 176 mg/d) was significantly greater for
desvenlafaxine (-12.64) compared with placebo (-8.33; P < .001). Statistical
separation from placebo was observed at week 1 and was sustained through week 8.
Both the perimenopausal and postmenopausal subgroups achieved significant
reductions in HDRS(17) total scores with desvenlafaxine treatment
(perimenopausal, P = .003; postmenopausal, P < .001). Response (58.6%) and
remission (38.2%) rates were significantly higher for desvenlafaxine compared
with placebo (31.6% [P < .001] and 22.4% [P = .008], respectively). In all,
19/256 (7.4%) desvenlafaxine-treated patients and 4/125 (3.2%) placebo-treated
patients discontinued due to adverse events. Treatment-emergent adverse events
were reported by 94/125 (75.2%) placebo-treated patients and 218/256 (85.2%)
desvenlafaxine-treated patients.
CONCLUSIONS: Short-term treatment with desvenlafaxine was effective and generally
well tolerated in perimenopausal and postmenopausal women with MDD.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00369343.
|