Vilazodone for the treatment of major depressive disorder: Focusing on its clinical studies and mechanism of action

Psychiatry Investigation

Volumn 12, Issue 2, 2015, Pages 155-163

  Wang, Sheng Min ^a   Han, Changsu ^b   Lee, Soo Jung ^a   Patkar, Ashwin A ^c   Masand, Prakash S ^d   Pae, Chi Un ^a,c  

^a The Catholic University of Korea College of Medicine   (South Korea)

^b Korea University College of Medicine   (South Korea)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d Global Medical Education Inc   (United States)

Author keywords

Antidepressant; Efficacy; Novel mechanism; Safety; Vilazodone

Indexed keywords

MOXIFLOXACIN; SEROTONIN 1A AGONIST; SEROTONIN UPTAKE INHIBITOR; VILAZODONE;

DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HEADACHE; HUMAN; IC50; INSOMNIA; LETHARGY; MAJOR DEPRESSION; MAXIMUM PLASMA CONCENTRATION; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); NAUSEA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SEXUAL DYSFUNCTION; SLEEP WAKING CYCLE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; XEROSTOMIA;

EID: 84928266702     PISSN: 17383684     EISSN: 19763026     Source Type: Journal    
DOI: 10.4306/pi.2015.12.2.155     Document Type: Review

References (57)

1. Egede LE. Major depression in individuals with chronic medical disorders: prevalence, correlates and association with health resource utilization, lost productivity and functional disability. Gen Hosp Psychiatry 2007;29:409-416.
2. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003;289: 3095-3105.
3. Kocsis JH, Leon AC, Markowitz JC, Manber R, Arnow B, Klein DN, et al. Patient preference as a moderator of outcome for chronic forms of major depressive disorder treated with nefazodone, cognitive behavioral analysis system of psychotherapy, or their combination. J Clin Psychiatry 2009;70:354-361.
4. Massart R, Mongeau R, Lanfumey L. Beyond the monoaminergic hypothesis: neuroplasticity and epigenetic changes in a transgenic mouse model of depression. Philos Trans R Soc Lond B Biol Sci 2012;367: 2485-2494.
5. Bortolozzi A, Celada P, Artigas F. Novel Therapeutic strategies in major depression: focus on RNAi and ketamine. Curr Pharm Des 2014;20: 3848-3860.
6. Malhi GS, Hitching R, Berk M, Boyce P, Porter R, Fritz K. Pharmacological management of unipolar depression. Acta Psychiatr Scand Suppl 2013;(443):6-23.
7. Trivedi MH, Fava M, Wisniewski SR, Thase ME, Quitkin F, Warden D, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med 2006;354:1243-1252.
8. Blier P, Ward HE, Tremblay P, Laberge L, Hebert C, Bergeron R. Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study. Am J Psychiatry 2010;167:281-288.
9. Taneja C, Papakostas GI, Jing Y, Baker RA, Forbes RA, Oster G. Costeffectiveness of adjunctive therapy with atypical antipsychotics for acute treatment of major depressive disorder. Ann Pharmacother 2012; 46:642-649.
10. Barowsky J, Schwartz TL. An evidence-based approach to augmentation and combination strategies for: treatment-resistant depression. Psychiatry (Edgmont) 2006;3:42-61.
11. Forest Pharmaceuticals I. Viibryd (Vilazodone) Prescribing Information. Available at: http://www.frx.com/pi/viibryd_pi.pdf. April 2011 [cited 20 July 2012].
12. Hughes ZA, Starr KR, Langmead CJ, Hill M, Bartoszyk GD, Hagan JJ, et al. Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone. Eur J Pharmacol 2005;510:49-57.
13. Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin 2014;30: 263-270.
14. Khan A, Sambunaris A, Edwards J, Ruth A, Robinson DS. Vilazodone in the treatment of major depressive disorder: efficacy across symptoms and severity of depression. Int Clin Psychopharmacol 2014;29: 86-92.
15. Khan A, Cutler AJ, Kajdasz DK, Gallipoli S, Athanasiou M, Robinson DS, 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;72:441-447.
16. Duxon MS, Starr KR, Upton N. Latency to paroxetine-induced anxiolysis in the rat is reduced by co-administration of the 5-HT(1A) receptor antagonist WAY100635. Br J Pharmacol 2000;130:1713-1719.
17. Hogg S, Dalvi A. Acceleration of onset of action in schedule-induced polydipsia: combinations of SSRI and 5-HT1A and 5-HT1B receptor antagonists. Pharmacol Biochem Behav 2004;77:69-75.
18. Lindsey WT. Vilazodone for the treatment of depression. Ann Pharmacother 2011;45:946-953.
19. 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;33:199-206.
20. US Food and Drug Administration. Vilazodone Drug Approval Package. Available at http://www.accessdata.fda.gov/drugsatfda_docs/ nda/2011/022567Orig1s000StatR.pdf. Accessed on February 10, 2014.
21. Bartoszyk GD, Hegenbart R, Ziegler H. EMD 68843, a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties. Eur J Pharmacol 1997;322:147-153.
22. Sorbera LA, Rabassada X, Silvestre J, Castaner J. Vilazodone hydrochloride. Antidepressant, 5-HT1A partial agonist, 5-HT reuptake inhibitor. Drug Future 2001;26:247-252.
23. Celada P, Bortolozzi A, Artigas F. Serotonin 5-HT1A receptors as targets for agents to treat psychiatric disorders: rationale and current status of research. CNS Drugs 2013;27:703-716.
24. Sprouse JS, Aghajanian GK. Electrophysiological responses of serotoninergic dorsal raphe neurons to 5-HT1A and 5-HT1B agonists. Synapse 1987;1:3-9.
25. Casanovas JM, Lesourd M, Artigas F. The effect of the selective 5-HT1A agonists alnespirone (S-20499) and 8-OH-DPAT on extracellular 5-hydroxytryptamine in different regions of rat brain. Br J Pharmacol 1997;122:733-741.
26. Lanfumey L, Hamon M. Central 5-HT(1A) receptors: regional distribution and functional characteristics. Nucl Med Biol 2000;27:429-435.
27. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biol Psychiatry 2003;53:193-203.
28. Blier P, Abbott FV. Putative mechanisms of action of antidepressant drugs in affective and anxiety disorders and pain. J Psychiatry Neurosci 2001;26:37-43.
29. Bel N, Artigas F. Chronic treatment with fluvoxamine increases extracellular serotonin in frontal cortex but not in raphe nuclei. Synapse 1993;15:243-245.
30. Celada P, Puig M, Amargos-Bosch M, Adell A, Artigas F. The therapeutic role of 5-HT1A and 5-HT2A receptors in depression. J Psychiatry Neurosci 2004;29:252-265.
31. Hjorth S, Bengtsson HJ, Kullberg A, Carlzon D, Peilot H, Auerbach SB. Serotonin autoreceptor function and antidepressant drug action. J Psychopharmacol 2000;14:177-185.
32. Briley M, Moret C. Neurobiological mechanisms involved in antidepressant therapies. Clin Neuropharmacol 1993;16:387-400.
33. Starr KR, Price GW, Watson JM, Atkinson PJ, Arban R, Melotto S, et al. SB-649915-B, a novel 5-HT1A/B autoreceptor antagonist and serotonin reuptake inhibitor, is anxiolytic and displays fast onset activity in the rat high light social interaction test. Neuropsychopharmacology 2007;32:2163-2172.
34. Hughes ZA, Starr KR, Scott CM, Newson MJ, Sharp T, Watson JM, et al. Simultaneous blockade of 5-HT1A/B receptors and 5-HT transporters results in acute increases in extracellular 5-HT in both rats and guinea pigs: in vivo characterization of the novel 5-HT1A/B receptor antagonist/5-HT transport inhibitor SB-649915-B. Psychopharmacology (Berl) 2007;192:121-133.
35. Dawson LA, Watson JM. Vilazodone: a 5-HT1A receptor agonist/serotonin transporter inhibitor for the treatment of affective disorders. CNS Neurosci Ther 2009;15:107-117.
36. Wang SM, Han C, Lee SJ, Patkar AA, Masand PS, Pae CU. A review of current evidence for vilazodone in major depressive disorder. Int J Psychiatry Clin Pract 2013;17:160-169.
37. Page ME, Cryan JF, Sullivan A, Dalvi A, Saucy B, Manning DR, et al. Behavioral and neurochemical effects of 5-(4-[4-(5-Cyano-3-indolylbutyl)-butyl]-1-piperazinyl)-benzofuran-2-carboxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine(1A) receptor partial agonist. J Pharmacol Exp Ther 2002;302:1220-1227.
38. Ashby CR Jr, Kehne JH, Bartoszyk GD, Renda MJ, Athanasiou M, Pierz KA, et al. Electrophysiological evidence for rapid 5-HT(1)A autoreceptor inhibition by vilazodone, a 5-HT(1)A receptor partial agonist and 5-HT reuptake inhibitor. Eur J Pharmacol 2013;714:359-365.
39. Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, et al. Vilazodone: clinical basis for the US Food and Drug Administration’s approval of a new antidepressant. J Clin Psychiatry 2011;72: 1166-1173.
40. 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;70:326-333.
41. 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;31:643-646.
42. Khan A. Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depression. Expert Opin Investig Drugs 2009;18: 1753-1764.
43. Murck H, Frieboes RM, Antonijevic IA, Steiger A. Distinct temporal pattern of the effects of the combined serotonin-reuptake inhibitor and 5-HT1A agonist EMD 68843 on the sleep EEG in healthy men. Psychopharmacology (Berl) 2001;155:187-192.
44. Quattrochi JJ, Mamelak AN, Binder D, Williams J, Hobson JA. Doserelated suppression of REM sleep and PGO waves by the serotonin-1 agonist eltoprazine. Neuropsychopharmacology 1993;8:7-13.
45. Driver HS, Flanigan MJ, Bentley AJ, Luus HG, Shapiro CM, Mitchell D. The influence of ipsapirone, a 5-HT1A agonist, on sleep patterns of healthy subjects. Psychopharmacology (Berl) 1995;117:186-192.
46. Sharpley AL, Williamson DJ, Attenburrow ME, Pearson G, Sargent P, Cowen PJ. The effects of paroxetine and nefazodone on sleep: a placebo controlled trial. Psychopharmacology (Berl) 1996;126:50-54.
47. Edwards J, Sperry V, Adams MH, Gallipoli S, Thorn MD, Longstreth J, et al. Vilazodone lacks proarrhythmogenic potential in healthy participants: a thorough ECG study. Int J Clin Pharmacol Ther 2013;51:456465.
48. Le Poul E, Laaris N, Doucet E, Laporte AM, Hamon M, Lanfumey L. Early desensitization of somato-dendritic 5-HT1A autoreceptors in rats treated with fluoxetine or paroxetine. Naunyn Schmiedebergs Arch Pharmacol 1995;352:141-148.
49. Li Q, Muma NA, Battaglia G, Van de Kar LD. A desensitization of hypothalamic 5-HT1A receptors by repeated injections of paroxetine: reduction in the levels of G(i) and G(o) proteins and neuroendocrine responses, but not in the density of 5-HT1A receptors. J Pharmacol Exp Ther 1997;282:1581-1590.
50. 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;66:356 368.
51. Clayton AH, Kennedy SH, Edwards J., Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med 2013;10:2465-2476.
52. Serretti A, Chiesa A. Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. J Clin Psychopharmacol 2009; 29:259-266.
53. Carstairs SD, Griffith EA, Alayin T, Ejike JC, Cantrell FL. Recurrent seizure activity in a child after acute vilazodone ingestion. Ann Emerg Med 2012;60:819-820.
54. Loane C, Politis M. Buspirone: what is it all about? Brain Res 2012; 1461:111-118.
55. Hoge EA, Ivkovic A, Fricchione GL. Generalized anxiety disorder: diagnosis and treatment. BMJ 2012;345:e7500.
56. Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 2006;163:1905-1917.
57. Rush AJ, Warden D, Wisniewski SR, Fava M, Trivedi MH, Gaynes BN, et al. STAR*D: revising conventional wisdom. CNS Drugs 2009;23: 627-647.