Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-11-26T01:57:35.938Z Has data issue: false hasContentIssue false
  • English
  • Français

A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder

Published online by Cambridge University Press:  07 November 2014

Alan D. Feiger ,
Karen A. Tourian ,
Gregory R. Rosas  and
S. Krishna Padmanabhan
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction: This research compares the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) versus placebo in treating major depressive disorder.

Methods: In this randomized, double-blind study, outpatients with major depressive disorder ≥18 years of age received desvenlafaxine 200–400 mg/day or placebo for 8 weeks. Efficacy endpoints included (primary) change in 17-item Hamilton Rating Scale for Depression score at the final evaluation (last observation carried forward, analysis of covariance) and (secondary) Clinical Global Impressions—Improvement and—Severity of Illness scales.

Results: The difference between desvenlafaxine (n=117) and placebo (n=118) on the primary endpoint was not significant (−9.1 vs −7.5, P=.078). Week 8 observed cases (desvenlafaxine, n=80; placebo, n=94) results were significant (−10.7 vs −7.9, P=.008). Differences at the final evaluation (last observation carried forward) were significant for Clinical Global Impressions—Improvement (2.9 vs 2.5, P=.037) and Clinical Global Impressions—Severity of Illness (−1.9 vs −1.2, P=.041). Discontinuation rates due to adverse events (AEs) were 12% and 3% for desvenlafaxine and placebo, respectively (P=.008). The most frequently reported AE associated with desvenlafaxine was nausea (36% vs 9% [placebo]).

Conclusion: In this study, the primary analysis did not show significant differences between desvenlafaxine and placebo; discontinuations due to AEs associated with the desvenlafaxine dose range may have contributed to the lack of statistical separation.

Type
Original Research
Information
CNS Spectrums , Volume 14 , Issue 1 , January 2009 , pp. 41 - 50
Copyright
Copyright © Cambridge University Press 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.World Health Organization Web site. Depression. Available at: http://www.who.int/mental_health/management/depression/definition/en/print.html. Accessed August 7, 2007.Google Scholar
2.Schatzberg, AF. Safety and tolerability of antidepressants: weighing the impact on treatment decisions. J Clin Psychiatry. 2007;68(suppl 8):26–34.Google Scholar
3.Khan, A, Leventhal, RM, Khan, SR, Brown, WA. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol. 2002;22:40–45.Google Scholar
4.Wyeth Pharmaceuticals. Project Listing. Neurosciences and Women's Health and Bone. Available at: http://www.wyeth.com/research/projects. Accessed May 21, 2008.Google Scholar
5. Pristiq [package insert]. Philadelphia, Penn: Wyeth Pharmaceuticals; 2008.Google Scholar
6.Boyer, P, Montgomery, S, Lepola, U, et al.Evaluation of the efficacy and safety of fixed doses of desvenlafaxine succinate at 50 mg and 100 mg in outpatients with major depressive disorder in a placebo-controlled trial. Int Clin Psychopharmacol. 2008;23:243–253.Google Scholar
7.Liebowitz, M, Manley, AL, Padmanabhan, SK, Ganguly, R, Tummala, R, Tourian, KA. Efficacy, safety, and tolerability of desvenlafaxine 50 mg/d and 100 mg/d in outpatients with major depressive disorder. Curr Med Res Opin. 2008;24:1877–1890.Google Scholar
8.DeMartinis, NA, Yeung, PP, Entsuah, R, Manley, AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007;68:677–688.CrossRefGoogle ScholarPubMed
9.Septien-Velez, L, Pitrosky, B, Padmanabhan, SK, Germain, J-M, Tourian, KA. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2007;22:338–347.CrossRefGoogle ScholarPubMed
10.Thase, ME, Kornstein, SG, Yeung, PP, et al. An integrated analysis of the efficacy of desvenlafaxine succinate compared with placebo in the treatment of major depressive disorder. Poster presented at: 47th Annual NCDEU meeting. June 11-14, 2007; Boca Raton, FL.Google Scholar
11.Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.Google Scholar
12.Hamilton, M. Hamilton Rating Scale for Depression (HAM-D). In: Rush, AJ, Pincus, HA, First, MB, et al, eds. Handbook of Psychiatric Measures. Washington, DC: American Psychiatric Association; 2000:526–529.Google Scholar
13.Guy, W. Clinical Global Impressions. ECDEU Assessment Manual for Psychopharmacology, Revised 1976. Bethesda, Md: US Department of Health, Education and Welfare, National Institute of Mental Health; 1976:217–222.Google Scholar
14.Lipman, RS. Differentiating anxiety and depression in anxiety disorders: use of rating scales. Psychopharmacol Bull. 1982;18:69–77.Google Scholar
15.Raskin, A. Age-sex differences in response to antidepressant drugs. J Nerv Ment Dis. 1974;159:120–130.CrossRefGoogle ScholarPubMed
16.Montgomery, SA, Åsberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–389.Google Scholar
17.Bech, P. Psychometric developments of the Hamilton Scales: the spectrum of depression, dysthymia, and anxiety. In: Bech, P, Coppen, A, eds. The Hamilton Scales. Berlin, Germany: Springer-Verlag, 1990:72–79.Google Scholar
18.The Medical Dictionary for Regulatory Activities. Available at: http://www.meddramsso.com/MSSOWeb/index.htm. Accessed December 11, 2008.Google Scholar
19.Kirsch, I, Deacon, BJ, Huedo-Medina, TB, Scoboria, A, Moore, TJ, Johnson, BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5:e45.Google Scholar
20.Fava, M, Rush, AJ, Trivedi, MH, et al.Background and rationale for the sequenced treatment alternatives to relieve depression (STAR*D) study. Psychiatr Clin North Am. 2003;26:457–494.Google Scholar