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Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.
J Clin Psychiatry 2010; 71(8):1088-96JC

Abstract

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.

Authors+Show Affiliations

Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, Richmond, VA 23209-0710, USA. skornstein@mcvh-vcu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20797382

Citation

Kornstein, Susan G., et al. "Short-term Efficacy and Safety of Desvenlafaxine in a Randomized, Placebo-controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder." The Journal of Clinical Psychiatry, vol. 71, no. 8, 2010, pp. 1088-96.
Kornstein SG, Jiang Q, Reddy S, et al. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010;71(8):1088-96.
Kornstein, S. G., Jiang, Q., Reddy, S., Musgnung, J. J., & Guico-Pabia, C. J. (2010). Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. The Journal of Clinical Psychiatry, 71(8), pp. 1088-96. doi:10.4088/JCP.10m06018blu.
Kornstein SG, et al. Short-term Efficacy and Safety of Desvenlafaxine in a Randomized, Placebo-controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder. J Clin Psychiatry. 2010;71(8):1088-96. PubMed PMID: 20797382.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. AU - Kornstein,Susan G, AU - Jiang,Qin, AU - Reddy,Sujana, AU - Musgnung,Jeff J, AU - Guico-Pabia,Christine J, PY - 2010/02/01/received PY - 2010/05/10/accepted PY - 2010/8/28/entrez PY - 2010/8/28/pubmed PY - 2010/9/10/medline SP - 1088 EP - 96 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 71 IS - 8 N2 - 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. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/20797382/Short_term_efficacy_and_safety_of_desvenlafaxine_in_a_randomized_placebo_controlled_study_of_perimenopausal_and_postmenopausal_women_with_major_depressive_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2010/v71n08/v71n0817.aspx DB - PRIME DP - Unbound Medicine ER -