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Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.
J Clin Psychiatry. 2013 Oct; 74(10):1010-7.JC

Abstract

OBJECTIVE

Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.

METHOD

This phase 4, multicenter, parallel-group, randomized, double-blind, placebo-controlled study was conducted from June 30, 2010, to June 8, 2011. Patients received placebo or desvenlafaxine 50 mg/d (1:1 ratio; n = 217 in each group). The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale (HDRS17) total score. Secondary outcome measures included change in the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Improvement scale (CGI-I), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Visual Analog Scale-Pain Intensity (VAS-PI).

RESULTS

At end point, compared to placebo, desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores (last-observation-carried-forward analysis; adjusted mean change from baseline -9.9 vs -8.1, respectively; P = .004) and significant improvements on the CGI-I (P < .001), MADRS (P = .002), SDS (P = .038), and VAS-PI (P < .001). Improvements on the SDS and VAS-PI reached significance by week 2. Desvenlafaxine was generally safe and well tolerated.

CONCLUSIONS

Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women, with significant benefits on pain and functional outcomes evident as early as week 2. The safety and tolerability of desvenlafaxine were consistent with data in other populations.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01121484.

Authors+Show Affiliations

Psychiatry and Neurobehavioral Sciences, University of Virginia, 2955 Ivy Rd, Northridge Ste 210, Charlottesville, VA 22903 ahc8v@virginia.edu.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24229754

Citation

Clayton, Anita H., et al. "Efficacy and Safety of Desvenlafaxine 50 Mg/d in a Randomized, Placebo-controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder." The Journal of Clinical Psychiatry, vol. 74, no. 10, 2013, pp. 1010-7.
Clayton AH, Kornstein SG, Dunlop BW, et al. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013;74(10):1010-7.
Clayton, A. H., Kornstein, S. G., Dunlop, B. W., Focht, K., Musgnung, J., Ramey, T., Bao, W., & Ninan, P. T. (2013). Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. The Journal of Clinical Psychiatry, 74(10), 1010-7. https://doi.org/10.4088/JCP.12m08065
Clayton AH, et al. Efficacy and Safety of Desvenlafaxine 50 Mg/d in a Randomized, Placebo-controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder. J Clin Psychiatry. 2013;74(10):1010-7. PubMed PMID: 24229754.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. AU - Clayton,Anita H, AU - Kornstein,Susan G, AU - Dunlop,Boadie W, AU - Focht,Kristen, AU - Musgnung,Jeff, AU - Ramey,Tanya, AU - Bao,Weihang, AU - Ninan,Philip T, PY - 2012/07/31/received PY - 2013/05/02/accepted PY - 2013/11/16/entrez PY - 2013/11/16/pubmed PY - 2014/4/8/medline SP - 1010 EP - 7 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 74 IS - 10 N2 - OBJECTIVE: Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. METHOD: This phase 4, multicenter, parallel-group, randomized, double-blind, placebo-controlled study was conducted from June 30, 2010, to June 8, 2011. Patients received placebo or desvenlafaxine 50 mg/d (1:1 ratio; n = 217 in each group). The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale (HDRS17) total score. Secondary outcome measures included change in the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Improvement scale (CGI-I), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Visual Analog Scale-Pain Intensity (VAS-PI). RESULTS: At end point, compared to placebo, desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores (last-observation-carried-forward analysis; adjusted mean change from baseline -9.9 vs -8.1, respectively; P = .004) and significant improvements on the CGI-I (P < .001), MADRS (P = .002), SDS (P = .038), and VAS-PI (P < .001). Improvements on the SDS and VAS-PI reached significance by week 2. Desvenlafaxine was generally safe and well tolerated. CONCLUSIONS: Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women, with significant benefits on pain and functional outcomes evident as early as week 2. The safety and tolerability of desvenlafaxine were consistent with data in other populations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01121484. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/24229754/Efficacy_and_safety_of_desvenlafaxine_50_mg/d_in_a_randomized_placebo_controlled_study_of_perimenopausal_and_postmenopausal_women_with_major_depressive_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2013/v74n10/v74n1013.aspx DB - PRIME DP - Unbound Medicine ER -