Vortioxetine for major depressive disorder: An indirect comparison with duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, using number needed to treat, number needed to harm, and likelihood to be helped or harmed

Journal of Affective Disorders

Volumn 196, Issue , 2016, Pages 225-233

  Citrome, Leslie ^a  

^a NEW YORK MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DULOXETINE; ESCITALOPRAM; MILNACIPRAN; PLACEBO; SERTRALINE; VENLAFAXINE; VILAZODONE; VORTIOXETINE; ANTIDEPRESSANT AGENT; CITALOPRAM; SEROTONIN UPTAKE INHIBITOR;

DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HAMILTON DEPRESSION RATING SCALE; HUMAN; MAJOR DEPRESSION; META ANALYSIS; MONTGOMERY ASBERG DEPRESSION RATING SCALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; ADULT; DEPRESSIVE DISORDER, MAJOR; FEMALE; MALE; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; TREATMENT OUTCOME;

ADULT; ANTIDEPRESSIVE AGENTS; CITALOPRAM; DEPRESSIVE DISORDER, MAJOR; DULOXETINE HYDROCHLORIDE; FEMALE; HUMANS; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; SEROTONIN UPTAKE INHIBITORS; SERTRALINE; TREATMENT OUTCOME; VENLAFAXINE HYDROCHLORIDE; VILAZODONE HYDROCHLORIDE;

EID: 84959505051     PISSN: 01650327     EISSN: 15732517     Source Type: Journal    
DOI: 10.1016/j.jad.2016.02.042     Document Type: Review

References (71)

1. E. Alvarez, V. Perez, M. Dragheim, H. Loft, and F. Artigas A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder Int. J. Neuropsychopharmacol. 15 2012 589 600
2. Anon, 2013. Takeda and Lundbeck announce FDA approval of Brintellix™ (vortioxetine) for treatment of adults with major depressive disorder. Press release. 1 October 2013. Available from: (http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=794050) accessed (01.02.15).
3. G.M. Asnis, A. Bose, C.P. Gommoll, C. Chen, and W.M. Greenberg Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study J. Clin. Psychiatry 74 2013 242 248
4. D. Bakish, A. Bose, C. Gommoll, C. Chen, R. Nunez, W.M. Greenberg, M. Liebowitz, and A. Khan Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study J. Psychiatry Neurosci. 39 2014 40 49
5. D.S. Baldwin, H. Loft, and M. Dragheim A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD) Eur. Neuropsychopharmacol. 22 2012 482 491
6. J.P. Boulenger, H. Loft, and C.K. Olsen Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder Int. Clin. Psychopharmacol. 29 2014 138 149
7. W.J. Burke, I. Gergel, and A. Bose Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients J. Clin. Psychiatry 63 2002 331 336
8. A. Cipriani, T.A. Furukawa, G. Salanti, J.R. Geddes, J.P. Higgins, R. Churchill, N. Watanabe, A. Nakagawa, I.M. Omori, H. McGuire, M. Tansella, and C. Barbui Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis Lancet 373 2009 746 758
9. L. Citrome, and T.A. Ketter When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed Int. J. Clin. Pract. 67 2013 407 411
10. L. Citrome, J.F. Goldberg, and K.B. Portland Placing transdermal selegiline for major depressive disorder into clinical context: number needed to treat, number needed to harm, and likelihood to be helped or harmed J. Affect. Disord. 151 2013 409 417
11. L. Citrome Compelling or irrelevant? Using number needed to treat can help decide Acta Psychiatr. Scand. 117 2008 412 419
12. L. Citrome Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications Curr. Drug. Saf. 4 2009 229 237
13. L. Citrome Adjunctive aripiprazole, olanzapine, or quetiapine for major depressive disorder: an analysis of number needed to treat, number needed to harm, and likelihood to be helped or harmed Postgrad. Med. 122 (Jul) 2010 39 48
14. L. Citrome Vilazodone for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int. J. Clin. Pract. 66 2012 356 368
15. L. Citrome Levomilnacipran for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int. J. Clin. Pract. 67 2013 1089 1104
16. L. Citrome Vortioxetine for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int. J. Clin. Pract. 68 2014 60 82
17. L. Citrome Vilazodone, levomilnacipran and vortioxetine for major depressive disorder: the 15-min challenge to sort these agents out Int. J. Clin. Pract. 69 2015 151 155
18. Committee for Medicinal Products for Human Use, 2013. Vortioxetine. Assessment report for an initial marketing authorisation application. 24 October 2013. Available from: (http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Public-assessment-report/human/002717/WC500159447.pdf) accessed (11.05.15).
19. L.A. Cunningham Once-daily venlafaxine extended release (XR) and venlafaxine immediate release (IR) in outpatients with major depression Venlafaxine XR 208 Study Group Ann. Clin. Psychiatry 9 1997 157 164
20. M.J. Detke, Y. Lu, D.J. Goldstein, R.K. McNamara, and M.A. Demitrack Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression J. Psychiatr. Res. 36 2002 383 390
21. M.J. Detke, Y. Lu, D.J. Goldstein, J.R. Hayes, and M.A. Demitrack Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial J. Clin. Psychiatry 63 2002 308 315
22. M.J. Detke, C.G. Wiltse, C.H. Mallinckrodt, R.K. McNamara, M.A. Demitrack, and I. Bitter Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial Eur. Neuropsychopharmacol. 14 2004 457 470
23. Diamand, F.; Danchenko, N.; Brignone, M.; Rive, B.; Perez, V.; Ereshefsky, L.; Francois, C.; Merikle, E.; 2015. Relative efficacy and tolerability of vortioxetine versus approved antidepressants for major depressive disorder: a meta-regression of clinical trials. Poster PMH47, International Society For Pharmacoeconomics and Outcomes Research 20th Annual International Meeting, Philadelphia, Pennsylvania, 16-20 May. Available From: (http://www.ispor.org/research-pdfs/49/pdffiles/PMH47.pdf) (accessed 11.05.15).
24. Eli Lilly, 2004d. Clinical Study Summary: Study F1J-MC-HMAT (Study Group A). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
25. Eli Lilly, 2004a. Clinical Study Summary: Study F1J-MC-HMBH (Study Group B). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
26. Eli Lilly, 2004b. Clinical Study Summary: Study F1J-MC-HMBH (Study Group A). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
27. Eli Lilly, 2004c. Clinical Study Summary: Study F1J-MC-HMAQ (Study Group A). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
28. Eli Lilly, 2004e. Clinical Study Summary: Study F1J-MC-HMAT (Study Group B). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
29. Eli Lilly, 2004f. Clinical Study Summary: Study F1J-MC-HMAQ (Study Group B). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) accessed (01.03.15).
30. Eli Lilly, 2005. Clinical Study Summary: Study F1J-MC-HMAY (Study Group A). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
31. Eli Lilly, 2006. Clinical Study Summary: Study F1J-MC-HMAY (Study Group B). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
32. Eli Lilly, 2007. Clinical Study Summary: Study F1J-US-HMCR (Study Group A). Available from: (http://www.lillytrials.com/results/Cymbalta.pdf) (accessed 01.02.15).
33. Evidence-Based Psychiatry Center, Nagoya City University Department of Psychiatry and Cognitive-Behavioral Medicine, 2015. Useful spreadsheets for daily evidence-based practices. Available from: (http://www.ebpcenter.com/spreadsheets/index.html) (accessed 01.03.15).
34. L.F. Fabre, F.S. Abuzzahab, M. Amin, J.L. Claghorn, J. Mendels, W.M. Petrie, S. Dubé, and J.G. Small Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo Biol. Psychiatry 38 1995 592 602
35. Food and Drug Administration, 2011. Review and Evaluation of Clinical Data - Vilazodone. NDA 22-567. 2011. Available from: (http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/022567Orig1s000TOC.cfm) (accessed 01.03.15).
36. Food and Drug Administration, 1991. Review and Evaluation of Clinical Data - Sertraline. NDA 19-839. Available from: (http://digitalcommons.ohsu.edu/fdadrug/27) accessed (01.03.15).
37. Food and Drug Administration, 2002. Review and Evaluation of Clinical Data - Escitalopram. NDA 21-323. Available from: (http://www.accessdata.fda.gov/drugsatfda-docs/nda/2002/21-323-Lexapro.cfm) (accessed 01.03.15)
38. Forest Laboratories, 2005. Synopsis Clinical Study Report. SCT-MD-01. Available from: (http://www.forestclinicaltrials.com) (accessed 01.02.15).
39. Forest Laboratories, 2013. Synopsis Clinical Study Report. LVM-MD-02. Available from: (http://www.forestclinicaltrials.com) (accessed 01.02.15).
40. T.A. Furukawa, and S. Leucht How to obtain NNT from cohen's d: comparison of two methods PLoS. One 6 2011 e19070
41. A.J. Gelenberg, M.P. Freeman, J.C. Markowitz, J.F. Rosenbaum, M.E. Thase, H.H. Trivedi, and R.S. Van Rhoads Practice Guideline for the Treatment of Patients with Major Depressive Disorder Third edition 2010 American Psychiatric Association Arlington, VA
42. D.J. Goldstein, Y. Lu, M.J. Detke, C. Wiltse, C. Mallinckrodt, and M.A. Demitrack Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine J. Clin. Psychopharmacol. 24 2004 389 399
43. Gommol, C.; Bose, A.; Li, H.; Edwards, J.; 2011. A randomized double-blind, placebo-controlled, flexible-dose study of levomilnacipran in patients with major depressive disorder. Poster, US Psychiatric and Mental Health Congress 24th Annual Meeting, (Las Vegas, Nevada), 7-10 November.
44. N. Henigsberg, A.R. Mahableshwarkar, P. Jacobsen, Y. Chen, and M.E. Thase A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder J. Clin. Psychiatry 73 2012 953 959
45. P.L. Jacobsen, A.R. Mahableshwarkar, Y. Chen, L. Chrones, and A.H. Clayton Effect of vortioxetine vs. escitalopram on sexual functioning in adults with well-treated major depressive disorder experiencing SSRI-induced sexual dysfunction J. Sex. Med. 12 2015 2036 2048
46. P.L. Jacobsen, A.R. Mahableshwarkar, M. Serenko, S. Chan, and M.H. Trivedi A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder J. Clin. Psychiatry 76 2015 575 582
47. R. Jain, A.R. Mahableshwarkar, P.L. Jacobsen, Y. Chen, and M.E. Thase A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder Int. J. Neuropsychopharmacol. 16 2013 313 321
48. C. Katona, T. Hansen, and C.K. Olsen A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder Int. Clin. Psychopharmacol. 27 2012 215 223
49. A. Khan, A.J. Cutler, D.K. Kajdasz, S. Gallipoli, M. Athanasiou, D.S. Robinson, H. Whalen, and C.R. Reed A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder J. Clin. Psychiatry 72 2011 441 447
50. U.M. Lepola, H. Loft, and E.H. Reines Escitalopram (10-20 mg/day) IS effective and well tolerated in a placebo-controlled study in depression in primary care Int. Clin. Psychopharmacol. 18 2003 211 217
51. P.M. Llorca, C. Lançon, M. Brignone, B. Rive, S. Salah, L. Ereshefsky, and C. Francois Relative efficacy and tolerability of vortioxetine versus selected antidepressants by indirect comparisons of similar clinical studies Curr. Med. Res. Opin. 30 2014 2589 2606
52. Lundbeck, 2005. Clinical Trial Report Summary - Study 99003. Available From: (http://www.lundbeck.com/upload/trials/files/pdf/completed/99003-CTRS-final-30Dec2005.pdf) (accessed 01.02.15).
53. A.R. Mahableshwarkar, P.L. Jacobsen, and Y. Chen A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder Curr. Med. Res. Opin. 29 2013 217 226
54. A.R. Mahableshwarkar, P.L. Jacobsen, Y. Chen, M. Serenko, and M.H. Trivedi A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD Psychopharmacol. (Berl.) 232 2015 2061 2070
55. A.R. Mahableshwarkar, P.L. Jacobsen, M. Serenko, Y. Chen, and M.H. Trivedi A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder J. Clin. Psychiatry 76 2015 583 591
56. A.R. Mahableshwarkar, J. Zajecka, W. Jacobson, Y. Chen, and R.S. Keefe A randomized, placebo-controlled, active-reference, double-blind, flexible-dose study of the efficacy of vortioxetine on cognitive function in major depressive disorder Neuropsychopharmacology 40 2015 2025 2037
57. R.S. McIntyre, S. Lophaven, and C.K. Olsen A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults Int. J. Neuropsychopharmacol. 17 2014 1557 1567
58. S.A. Montgomery, L. Mansuy, A. Ruth, A. Bose, H. Li, and D. Li Efficacy and safety of levomilnacipran sustained release in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled, proof-of-concept study J. Clin. Psychiatry 74 2013 363 369
59. A. Mørk, A. Pehrson, L.T. Brennum, S.M. Nielsen, H. Zhong, A.B. Lassen, S. Miller, L. Westrich, N.J. Boyle, C. Sánchez, C.W. Fischer, N. Liebenberg, G. Wegener, C. Bundgaard, S. Hogg, B. Bang-Andersen, and T.B. Stensbøl Pharmacological effects of Lu AA21004: a novel multimodal compound for the treatment of major depressive disorder J. Pharmacol. Exp. Ther. 340 2012 666 675
60. Nishimura, A.; Hirochi, K.; Asari, K.; Otake, K.; Mahableshwarkar, A.R.; 2014. A multinational, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vortioxetine 5, 10, and 20 mg in adults with major depressive disorder. In: Poster 106, 27th Annual U.S. Psychiatric and Mental Health Congress, Orlando, Florida, 20-23 September.
61. T.A. Pigott, A. Prakash, L.M. Arnold, S.T. Aaronson, C.H. Mallinckrodt, and M.M. Wohlreich Duloxetine versus escitalopram and placebo: an 8-month, double-blind trial in patients with major depressive disorder Curr. Med. Res. Opin. 23 2007 1303 1318
62. F.W. Reimherr, G. Chouinard, C.K. Cohn, J.O. Cole, T.M. Itil, Y.D. LaPierre, H.L. Masco, and J. Mendels Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression J. Clin. Psychiatry 51 1990 18 27
63. K. Rickels, M. Athanasiou, D.S. Robinson, M. Gibertini, H. Whalen, and C.R. Reed Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial J. Clin. Psychiatry 70 2009 326 333
64. R.L. Rudolph, and A.D. Feiger A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression J. Affect. Disord. 56 1999 171 181
65. A. Sambunaris, A. Bose, C.P. Gommoll, C. Chen, W.M. Greenberg, and D.V. Sheehan A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder J. Clin. Psychopharmacol. 34 2014 47 56
66. E. Schweizer, J. Feighner, L.A. Mandos, and K. Rickels Comparison of venlafaxine and imipramine in the acute treatment of major depression in outpatients J. Clin. Psychiatry 55 1994 104 108
67. A. Serretti, and A. Chiesa Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis J. Clin. Psychopharmacol. 29 2009 259 266
68. A. Serretti, and L. Mandelli Antidepressants and body weight: a comprehensive review and meta-analysis J. Clin. Psychiatry 71 2010 1259 1272
69. Takeda Pharmaceuticals America, 2014. BRINTELLIX (vortioxetine)tablets,fororal use. Prescribinginformation. Revised July2014.Availablefrom: http://general.takedapharm.com/content/file/pi.pdf?applicationcode=396066C6-E50F-4113-ABAD-54FE9525BF7E&filetypecode=BRINTELLIXPI? (accessed 01.02.15).
70. M.E. Thase Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The Venlafaxine XR 209 study group J. Clin. Psychiatry 58 1997 393 398
71. A. Wade, O. Michael Lemming, and K.B. Hedegaard Escitalopram 10 mg/day is effective and well tolerated in a placebo-controlled study in depression in primary care Int. Clin. Psychopharmacol. 17 2002 95 102