Efficacy of desvenlafaxine 50 mg compared with placebo in patients with moderate or severe major depressive disorder: A pooled analysis of six randomized, double-blind, placebo-controlled studies

International Clinical Psychopharmacology

Volumn 28, Issue 6, 2013, Pages 312-321

  Papakostas, George I ^a   Culpepper, Larry ^b   Fayyad, Rana S ^c   Musgnung, Jeff ^c   Guico Pabia, Christine J ^c  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PFIZER INC   (United States)

Author keywords

Antidepressants; Depression; Desvenlafaxine; Treatment efficacy

Indexed keywords

DESVENLAFAXINE; PLACEBO;

ARTICLE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FUNCTIONAL DISEASE; HAMILTON SCALE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY (TOPIC); NUMBERS NEEDED TO TREAT; OUTCOME ASSESSMENT; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; SHEEHAN DISABILITY SCALE;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; CYCLOHEXANOLS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PLACEBO EFFECT; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84885308121     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0b013e3283638fbd     Document Type: Article

References (59)

1. American Psychiatric Association (1994). Diagnostic and Statistical Manual of Mental Disorders DSM-IV. 4th ed. Washington, DC: American Psychiatric Publishing
2. American Psychiatric Association (2000). Diagnostic and Statistical Manual of Mental Disorders, Text Revision: DSM-IV-TR. 4th ed. Washington, DC: American Psychiatric Publishing
3. American Psychiatric Association (2010). Practice guideline for the treatment of patients with major depressive disorder. Arlington, VA: American Psychiatric Association. pp. 1-152
4. Auquier P, Robitail S, Llorca P-M, Rive B (2003). Comparison of escitalopram and citalopram efficacy: A meta-Analysis. Int J Psychiatr Clin Pract 7: 259-268
5. Bauer M, Tharmanathan P, Volz HP, Moeller HJ, Freemantle N (2009). The effect of venlafaxine compared with other antidepressants and placebo in the treatment of major depression: A meta-Analysis. Eur Arch Psychiatry Clin Neurosci 259:172-185
6. Bech P, Tanghoj P, Cialdella P, Andersen HF, Pedersen AG (2004). Escitalopram dose-response revisited: An alternative psychometric approach to evaluate clinical effects of escitalopram compared to citalopram and placebo in patients with major depression. Int J Neuropsychopharmacol 7:283-290
7. Boyer P, Montgomery S, Lepola U, Germain JM, Brisard C, Ganguly R, et al. (2008). Efficacy, safety, and tolerability of fixed-Dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial. Int Clin Psychopharmacol 23:243-253
8. Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, et al. (2009). Comparative efficacy and acceptability of 12 new-generation antidepressants: A multiple-Treatments meta-Analysis. Lancet 373:746-758
9. Clayton AH, Kornstein SG, Rosas G, Guico-Pabia C, Tourian KA (2009). An integrated analysis of the safety and tolerability of desvenlafaxine compared with placebo in the treatment of major depressive disorder. CNS Spectr 14:183-195
10. DeMartinis NA, Yeung PP, Entsuah R, Manley AL (2007). A double-blind, placebocontrolled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry 68: 677-688
11. Dunlop BW, Reddy S, Yang L, Lubaczewski S, Focht K, Guico-Pabia CJ (2011). Symptomatic and functional improvement in employed depressed patients: A double-blind clinical trial of desvenlafaxine versus placebo. J Clin Psychopharmacol 31:569-576
12. Dunner DL, Lipschitz A, Pitts CD, Davies JT (2005). Efficacy and tolerability of controlled-release paroxetine in the treatment of severe depression: Post hoc analysis of pooled data from a subset of subjects in four double-blind clinical trials. Clin Ther 27:1901-1911
13. Eckert L, Lancon C (2006). Duloxetine compared with fluoxetine and venlafaxine: Use of meta-regression analysis for indirect comparisons. BMC Psychiatry 6:30
14. Einarson TR, Arikian SR, Casciano J, Doyle JJ (1999). Comparison of extendedrelease venlafaxine, selective serotonin reuptake inhibitors, and tricyclic antidepressants in the treatment of depression: A meta-Analysis of randomized controlled trials. Clin Ther 21:296-308
15. Endicott J, Dorries KM (2009). Functional outcomes in MDD: Established and emerging assessment tools. Am J Manag Care 15:S328-S334
16. Entsuah AR, Rudolph RL, Chitra R (1995). Effectiveness of venlafaxine treatment in a broad spectrum of depressed patients: A meta-Analysis. Psychopharmacol Bull 31:759-766
17. Gartlehner G, Hansen R, Thieda P, DeVeaugh-Geiss AM, Gaynes BN, Krebs EE, et al. (2007). Comparative effectiveness of second-generation antidepressants in the pharmacologic treatment of adult depression. Agency for Healthcare Research and Quality Publication No. 07-EHC007-EF. pp. 1-169
18. Gibbons RD, Hur K, Brown CH, Davis JM, Mann JJ (2012). Benefits from antidepressants: Synthesis of 6-week patient-level outcomes from doubleblind placebo-controlled randomized trials of fluoxetine and venlafaxine. Arch Gen Psychiatry 69:572-579
19. Guelfi JD, Ansseau M, Timmerman L, Korsgaard S (2001). Mirtazapine versus venlafaxine in hospitalized severely depressed patients with melancholic features. J Clin Psychopharmacol 21:425-431
20. Gutierrez MA, Stimmel GL, Aiso JY (2003). Venlafaxine: A 2003 update. Clin Ther 25:2138-2154
21. Hansen RA, Gartlehner G, Lohr KN, Gaynes BN, Carey TS (2005). Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder. Ann Intern Med 143:415-426
22. Isacsson G, Adler M (2012). Randomized clinical trials underestimate the efficacy of antidepressants in less severe depression. Acta Psychiatr Scand 125:453-459
23. Iwata N, Tourian KA, Hwang E, Mele L, Vialet C. for the Study 3359 Investigators (2013). Efficacy and safety of desvenlafaxine 25 and 50 mg/day in a randomized, placebo-controlled study of depressed outpatients. J Psychiatr Pract 19:5-14
24. Kennedy SH, Andersen HF, Lam RW (2006). Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: A meta-Analysis. J Psychiatry Neurosci 31:122-131
25. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, et al. (2003). The epidemiology of major depressive disorder: Results from the National Comorbidity Survey Replication (NCS-R). JAMA 289:3095-3105
26. Kienke AS, Rosenbaum JF (2000). Efficacy of venlafaxine in the treatment of severe depression. Depress Anxiety 12 (Suppl 1):50-54
27. Kilts CD, Wade AG, Andersen HF, Schlaepfer TE (2009). Baseline severity of depression predicts antidepressant drug response relative to escitalopram. Expert Opin Pharmacother 10:927-936
28. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT (2008). Initial severity and antidepressant benefits: A meta-Analysis of data submitted to the Food and Drug Administration. PLoS Med 5:e45
29. Kocsis JH, Schatzberg A, Rush AJ, Klein DN, Howland R, Gniwesch L, et al. (2002). Psychosocial outcomes following long-Term, double-blind treatment of chronic depression with sertraline vs placebo. Arch Gen Psychiatry 59:723-728
30. Koivumaa-Honkanen H, Tuovinen TK, Honkalampi K, Antikainen R, Hintikka J, Haatainen K, et al. (2008). Mental health and well-being in a 6-year follow-Up of patients with depression: Assessments of patients and clinicians. Soc Psychiatry Psychiatr Epidemiol 43:688-696
31. Kornstein SG, Li D, Mao Y, Larsson S, Andersen HF, Papakostas GI (2009). Escitalopram versus SNRI antidepressants in the acute treatment of major depressive disorder: Integrative analysis of four double-blind, randomized clinical trials. CNS Spectr 14:326-333
32. Liebowitz MR, Manley AL, Padmanabhan SK, Ganguly R, Tummala R, Tourian KA (2008). Efficacy, safety, and tolerability of desvenlafaxine 50 mg/day and 100 mg/day in outpatients with major depressive disorder. Curr Med Res Opin 24:1877-1890
33. Liebowitz MR, Tourian KA, Hwang E, Mele L. for the Study 3362 Investigators (2013). A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry 13:94
34. Merikangas KR, Ames M, Cui L, Stang PE, Ustun TB, Von Korff M, et al. (2007). The impact of comorbidity of mental and physical conditions on role disability in the US adult household population. Arch Gen Psychiatry 64:1180-1188
35. Montgomery SA, Baldwin DS, Blier P, Fineberg NA, Kasper S, Lader M, et al. (2007). Which antidepressants have demonstrated superior efficacy? A review of the evidence. Int Clin Psychopharmacol 22:323-329
36. Nemeroff CB, Entsuah R, Benattia I, Demitrack M, Sloan DM, Thase ME (2008). Comprehensive analysis of remission (COMPARE) with venlafaxine versus SSRIs. Biol Psychiatry 63:424-434
37. North CS, Suris AM, Davis M, Smith RP (2009). Toward validation of the diagnosis of posttraumatic stress disorder. Am J Psychiatry 166:34-41
38. Pande AC, Sayler ME (1993). Severity of depression and response to fluoxetine. Int Clin Psychopharmacol 8:243-245
39. Papakostas GI (2009). Major depressive disorder: Psychosocial impairment and key considerations in functional improvement. Am J Manag Care 15:S316-S321
40. Papakostas GI, Fan H, Tedeschini E (2012). Severe and anxious depression: Combining definitions of clinical sub-Types to identify patients differentially responsive to selective serotonin reuptake inhibitors. Eur Neuropsychopharmacol 22:347-355
41. Papakostas GI, Thase ME, Fava M, Nelson JC, Shelton RC (2007). Are antidepressant drugs that combine serotonergic and noradrenergic mechanisms of action more effective than the selective serotonin reuptake inhibitors in treating major depressive disorder? A meta-Analysis of studies of newer agents. Biol Psychiatry 62:1217-1227
42. Pfizer Inc, formerly Wyeth Research (2004). A multicenter, randomized, doubleblind, placebo-controlled study of 2 fixed doses of DVS-233 SR in adult outpatients with major depressive disorder: Final report. Protocol 0600D3-223-FR/PL/US/ZA, CSR-49148. Data on file
43. Romera I, Perez V, Menchon JM, Delgado-Cohen H, Polavieja P, Gilaberte I (2010). Social and occupational functioning impairment in patients in partial versus complete remission of a major depressive disorder episode. A sixmonth prospective epidemiological study. Eur Psychiatry 25:58-65
44. Schmitt AB, Bauer M, Volz HP, Moeller HJ, Jiang Q, Ninan PT, et al. (2009). Differential effects of venlafaxine in the treatment of major depressive disorder according to baseline severity. Eur Arch Psychiatry Clin Neurosci 259: 329-339
45. Septien-Velez L, Pitrosky B, Padmanabhan SK, Germain JM, Tourian KA (2007). A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. Int Clin Psychopharmacol 22:338-347
46. Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A (2011). Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol 26:75-83
47. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. (1998). The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 59 (Suppl 20):22-33
48. Shelton RC, Andorn AC, Mallinckrodt CH, Wohlreich MM, Raskin J, Watkin JG, et al. (2007a). Evidence for the efficacy of duloxetine in treating mild, moderate, and severe depression. Int Clin Psychopharmacol 22: 348-355
49. Shelton RC, Prakash A, Mallinckrodt CH, Wohlreich MM, Raskin J, Robinson MJ, et al. (2007b). Patterns of depressive symptom response in duloxetinetreated outpatients with mild, moderate or more severe depression. Int J Clin Pract 61:1337-1348
50. Smith D, Dempster C, Glanville J, Freemantle N, Anderson I (2002). Efficacy and tolerability of venlafaxine compared with selective serotonin reuptake inhibitors and other antidepressants: A meta-Analysis. Br J Psychiatry 180:396-404
51. Soares CN, Kornstein SG, Thase ME, Jiang Q, Guico-Pabia CJ (2009). Assessing the efficacy of desvenlafaxine for improving functioning and wellbeing outcome measures in patients with major depressive disorder: A pooled analysis of 9 double-blind, placebo-controlled, 8-week clinical trials. J Clin Psychiatry 70:1365-1371
52. Stahl SM, Entsuah R, Rudolph RL (2002). Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174
53. Thase ME, Entsuah AR, Rudolph RL (2001). Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry 178:234-241
54. Thase ME, Kornstein SG, Germain JM, Jiang Q, Guico-Pabia C, Ninan PT (2009). An integrated analysis of the efficacy of desvenlafaxine compared with placebo in patients with major depressive disorder. CNS Spectr 14: 144-154
55. Thase ME, Pritchett YL, Ossanna MJ, Swindle RW, Xu J, Detke MJ (2007). Efficacy of duloxetine and selective serotonin reuptake inhibitors: Comparisons as assessed by remission rates in patients with major depressive disorder. J Clin Psychopharmacol 27:672-676
56. Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D (2009). Desvenlafaxine 50 and 100 mg/day in the treatment of major depressive disorder: An 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther 31 (Pt 1):1405-1423
57. Trivedi MH, Dunner DL, Kornstein SG, Thase ME, Zajecka JM, Rothschild AJ, et al. (2010). Psychosocial outcomes in patients with recurrent major depressive disorder during 2 years of maintenance treatment with venlafaxine extended release. J Affect Disord 126:420-429
58. Trkulja V (2010). Is escitalopram really relevantly superior to citalopram in treatment of major depressive disorder? A meta-Analysis of head-To-head randomized trials. Croat Med J 51:61-73
59. Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc (2013). Pristiq [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc