Vilazodone for the treatment of major depressive disorder: An evidence-based review of its place in therapy

Core Evidence

Volumn 10, Issue , 2015, Pages 49-62

  Hellerstein, David J ^a,b   Flaxer, Joseph ^a  

^a Department of Psychiatry Columbia University ^*  (United States)

^b NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

Author keywords

Antidepressant; Major depression; Pharmacology; Vilazodone

Indexed keywords

CITALOPRAM; PLACEBO; SEROTONIN UPTAKE INHIBITOR; VILAZODONE;

ADOLESCENT DISEASE; ADULT DISEASE; ANXIETY; CHILDHOOD DISEASE; COMORBIDITY; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EVIDENCE BASED MEDICINE; GERIATRIC DISORDER; HUMAN; INSOMNIA; MAJOR DEPRESSION; META ANALYSIS; MONTGOMERY ASBERG DEPRESSION RATING SCALE; NAUSEA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PREGNANCY; PUERPERIUM; REMISSION; REVIEW; SEXUAL DYSFUNCTION; SUBSTANCE ABUSE; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING;

EID: 84928800753     PISSN: 15551741     EISSN: 1555175X     Source Type: Journal    
DOI: 10.2147/CE.S54075     Document Type: Review

References (72)

1. Murray CJ, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2013;380(9859):2197-2223.
2. World Health Organization. Global burden of mental disorders and the need for a comprehensive, coordinated response from health and social sectors at the country level. 2012. Available from: http://www. ghwatch.org/who-watch/wha65/mental. Accessed January 29, 2015.
3. Kessler RC, Birnbaum H, Demler O, et al. The prevalence and correlates of nonaffective psychosis in the National Comorbidity Survey Replication (NCS-R). Biol Psychiatry. 2005;58(8):668-676.
4. Greenberg PE, Kessler RC, Birnbaum HG, et al. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003;64(12):1465-1475.
5. Stewart JW, McGrath PJ, Blondeau C, et al. Combination antidepressant therapy for major depressive disorder: speed and probability of remission. J Psychiatr Res. 2014;52:7-14.
6. Geddes JR, Carney SM, Davies C, et al. Relapse prevention with antidepressant drug treatment in depressive disorders: a systematic review. Lancet. 2003;361(9358):653-661.
7. Trivedi M, Lin E, Katon W. Consensus recommendations for improving adherence, self-management, and outcomes in patients with depression. CNS Spectr. 2007;12(8 Suppl 13):1-27.
8. Hughes ZA, Starr KR, Langmead CJ, et al. Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone. Eur J Pharmacol. 2005;510(1):49-57.
9. Stahl SM. Mechanism of action of the SPARI vilazodone: serotonin 1A partial agonist and reuptake inhibitor. CNS Spectr. 2014;19(2):105-109.
10. Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR∗D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40.
11. Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(3):326-333.
12. Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72(4):441-447.
13. Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014;75(11):e1291-e1298.
14. Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. Epub December 12, 2014.
15. Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2011;28(1):27-39.
16. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biol Psychiatry. 2003;53(3):193-203.
17. Rickels K, Athanasiou M, Reed C. Vilazodone, a novel, dual-acting antidepressant: current status, future promise and potential for individualized treatment of depression. Per Med. 2009;6(2):217-224.
18. Fava M, Rush AJ, Alpert JE, et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR∗D report. Am J Psychiatry. 2008;165(3):342-351.
19. Thase ME, Chen D, Edwards J, Ruth A. Efficacy of vilazodone on anxiety symptoms in patients with major depressive disorder. Int Clin Psychopharmacol. 2014;29(6):351-356.
20. Friedman RA. A dry pipeline for psychiatric drugs. N Y Times. Epub August 19, 2013.
21. Murrough JW, Charney DS. Is there anything really novel on the antidepressant horizon? Curr Psychiatry Rep. 2012;14(6):643-649.
22. Krystal JH, Sanacora G, Duman RS. Rapid-acting glutamatergic antidepressants: the path to ketamine and beyond. Biol Psychiatry. 2013;73(12):1133-1141.
23. Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. 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. 2013;74(3):242-248.
24. Katona CL, Katona CP. New generation multi-modal antidepressants: focus on vortioxetine for major depressive disorder. Neuropsychiatr Dis Treat. 2014;10:349-354.
25. Mørk A, Montezinho LP, Miller S, et al. Vortioxetine (Lu AA21004), a novel multimodal antidepressant, enhances memory in rats. Pharmacol Biochem Behav. 2013;105:41-50.
26. Theunissen EL, Street D, Højer AM, Vermeeren A, van Oers A, Ramaekers JG. A randomized trial on the acute and steady-state effects of a new antidepressant, vortioxetine (Lu AA21004), on actual driving and cognition. Clin Pharmacol Ther. 2013;93(6):493-501.
27. Choi E, Zmarlicka M, Ehret MJ. Vilazodone: a novel antidepressant. Am J Health Syst Pharm. 2012;69(18):1551-1557.
28. Citrome L. 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. 2012;66(4):356-368.
29. Cruz MP. Vilazodone HCl (Viibryd): a serotonin partial agonist and reuptake inhibitor for the treatment of major depressive disorder. P T. 2012;37(1):28-31.
30. Culpepper L, Mathews M, Ghori R, Edwards J. Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms. Prim Care Companion CNS Disord. 2014;16(1).
31. Dawson LA, Watson JM. Vilazodone: a 5-HT1A receptor agonist/serotonin transporter inhibitor for the treatment of affective disorders. CNS Neurosci Ther. 2009;15(2):107-117.
32. Frampton JE. Vilazodone. CNS Drugs. 2011;25(7):615-627.
33. Griffin J, Pappas M. Drug Class Review. Second-Generation Antidepressants. Single Drug Addendum: Vilazodone HCl. Portland: Oregon Health and Science University; 2013.
34. Laughren TP, Gobburu J, Temple RJ, et al. Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant. J Clin Psychiatry. 2011;72(9):1166-1173.
35. Hansen RA, Gartlehner G, Lohr KN, Gaynes BN, Carey TS. Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder. Ann Intern Med. 2005;143(6):415-426.
36. 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(2):e45.
37. Fournier JC, DeRubeis RJ, Hollon SD, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303(1):47-53.
38. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR∗D report. Am J Psychiatry. 2006;163(11):1905-1917.
39. Machado-Vieira R, Salvadore G, Diazgranados N, Zarate Jr CA. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009;123(2):143-150.
40. Sachs GS, Nierenberg AA, Calabrese JR, et al. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007;356(17):1711-1722.
41. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington (VA): APA; 2013.
42. Bartoszyk GD, Hegenbart R, Ziegler H. EMD 68843, a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties. Eur J Pharmacol. 1997;322(2):147-153.
43. Schwarz TL, Siddiqui UA, Stahl SM. Vilazodone: a brief pharmacologic and clinical review of the novel serotonin partial agonist and reuptake inhibitor. Ther Adv Psychopharmacol. 2011;1(3):81-87.
44. Page ME, Cryan JF, Sullivan A, et al. Behavioral and neurochemical effects of 5-{4-[4-(5-Cyano-3- indolyl)-butyl)-butyl]-1-piperazinyl}-benzofuran-2-carboxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine1A receptor partial agonist. J Pharmacol Exp Ther. 2002;302(3):1220-1227.
45. Rabiner EA, Gunn RN, Wilkins MR, et al. Drug action at the 5-HT(1A) receptor in vivo: autoreceptor and postsynaptic receptor occupancy examined with PET and [carbonyl-(11)C]WAY-100635. Nucl Med Biol. 2000;27(5):509-513.
46. Patkar A, Rele S, Millet M, et al. A 8-week randomized, double-blind trial comparing efficacy, safety and tolerability of three vilazodone dose initiation strategies following switch from SSRIs or SNRIs in major depressive disorder. 2014. Available from: https://guidebook.com/guide/23750/poi/2064209. Accessed January 29, 2015.
47. Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011;31(5):643-646.
48. Mathews MG, Chen C, Dalei NR. Effects of vilazodone on sexual dysfunction in major depressive disorder: a randomized, double-blind trial with placebo and active controls. Poster presented at: ASCP 2014; October 8-10, 2014: Tampa, FL.
49. Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013;10(10):2465-2476.
50. Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial. Int Clin Psychopharmacol. 2015;30(2):75-81.
51. Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry. 1998;44(2):77-87.
52. Pierz KA, Thase ME. A review of vilazodone, serotonin, and major depressive disorder. Prim Care Companion CNS Disord. 2014;16(1).
53. Szegedi A, Jansen WT, Van Willigenburg A, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009;70(3):344-353.
54. Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. The efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a Phase IV trial. Int Clin Psychopharmacol. 2015;30(2):75-81.
55. Bielski RJ, Cunningham L, Horrigan JP, Londborg PD, Smith WT, Weiss K. Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry. 2008;69(4): 571-577.
56. Fava M, Rush A, Alpert J, et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR∗D report. Am J Psychiatry. 2008;165(3):342-351.
57. Alpert JE, Franznick DA, Hollander SB, Fava M. Gepirone extended-release treatment of anxious depression: evidence from a retrospective subgroup analysis in patients with major depressive disorder. J Clin Psychiatry. 2004;65(8):1069-1075.
58. Gammans R, Stringfellow J, Hvizdos AJ, et al. Use of buspirone in patients with generalized anxiety disorder and coexisting depressive symptoms. Neuropsychobiology. 1992;25(4):193-201.
59. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-55.
60. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56-62.
61. Nelson JC. Anxiety does not predict response to duloxetine in major depression: results of a pooled analysis of individual patient data from 11 placebo-controlled trials. Depress Anxiety. 2010;27(1):12-18.
62. Clayton AH, McGarvey EL, Clavet GJ. The Changes in Sexual Functioning Questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol Bull. 1997;33(4):731-745.
63. Keller A, McGarvey EL, Clayton AH. Reliability and construct validity of the Changes in Sexual Functioning Questionnaire short-form (CSFQ-14). J Sex Marital Ther. 2006;32(1):43-52.
64. McGahuey CA, Gelenberg AJ, Laukes CA, et al. The Arizona sexual experience scale (ASEX): reliability and validity. J Sex Marital Ther. 2000;26(1):25-40.
65. Boinpally R, Alcorn H, Adams MH, Longstreth J, Edwards J. Pharmacokinetics of vilazodone in patients with mild or moderate renal impairment. Clin Drug Investig. 2013;33(3):199-206.
66. Viibryd [package insert]. St Louis: Forest Pharmaceuticals; 2014.
67. Spina E, Trifirò G, Caraci F. Clinically significant drug interactions with newer antidepressants. CNS Drugs. 2012;26(1):39-67.
68. Boinpally R, Gad N, Gupta S, Periclou A. Influence of CYP3A4 induction/inhibition on the pharmacokinetics of vilazodone in healthy subjects. Clin Ther. 2014;36(11):1638-1649.
69. Morrison CM. A case report of the use of vilazodone in pregnancy. Prim Care Companion CNS Disord. 2013;16(2).
70. Phelps J. Four "new" antidepressants. Or are they? 2011. Available from: http://www.thecarlatreport.com/frees/four-%E2% 80%9Cnew%E2%80%9D-antidepressants-or-are-they-free-article. Accessed January 29, 2015.
71. Stanhope K, Dourish C. Effects of 5-HT1A receptor agonists, partial agonists and a silent antagonist on the performance of the conditioned emotional response test in the rat. Psychopharmacology. 1996;128(3):293-303.
72. Hamner M, Ulmer H, Horne D. Buspirone potentiation of antidepressants in the treatment of PTSD. Depress Anxiety. 1997;5(3):137-139.