Skip to main content
SpringerLink
Log in

Vilazodone

In Major Depressive Disorder

  • Adis Drug Profile
  • Published:
CNS Drugs Aims and scope Submit manuscript

Abstract

Vilazodone, a novel antidepressant agent that combines selective serotonin reuptake inhibitor (SSRI) activity and serotonin 5-HT1A receptor partial agonist activity in a single molecule, is indicated for the treatment of major depressive disorder (MDD) in the US. It is administered orally, once daily, with food.

At the recommended dosage of 40 mg/day, vilazodone was effective in the short-term treatment of MDD in adults, as evidenced by significant improvements versus placebo on multiple measures of depression, including the Montgomery-Åsberg Depression Rating Scale (MADRS) and the 17-item Hamilton Rating Scale for Depression (HAM-D-17), in two pivotal, 8-week, randomized, double-blind, phase III studies.

Significant differences between vilazodone and placebo on the MADRS and HAM-D-17 were seen after 1 week of treatment (first efficacy timepoint) in one of the two studies.

Long-term treatment with vilazodone 40mg/day was associated with an improvement from baseline in depressive symptoms in a 52-week, noncomparative, phase III study.

Vilazodone was generally well tolerated in the short- and long-term treatment of MDD, with diarrhoea and nausea being the most frequently occurring treatment-emergent adverse events.

Vilazodone had a minimal impact on sexual functioning in the three phase III studies.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II
Table III
Fig. 1

Similar content being viewed by others

References

  1. Greden JF. The burden of recurrent depression: causes, consequences, and future prospects. J Clin Psychiatry 2001; 62 Suppl. 22: 5–9

    Google Scholar 

  2. Kessler RC, Sonnega A, Bromet E, et al. Posttraumatic stress disorder in the national comorbidity survey. Arch Gen Psychiatry 1995; 52: 1048–60

    Article  PubMed  CAS  Google Scholar 

  3. Narasimhan M, Raynor JD, Jones AB. Depression in the medically ill: diagnostic and therapeutic implications. Curr Psychiatry Rep 2008; 10: 272–9

    Article  PubMed  Google Scholar 

  4. Kim D. Blues from the neighbourhood? Neighbourhood characteristics and depression. Epidemiol Rev 2008; 30: 101–17

    Article  PubMed  CAS  Google Scholar 

  5. Chang T, Fava M. The future of psychopharmacology of depression. J Clin Psychiatry 2010; 71(8): 971–5

    Article  PubMed  CAS  Google Scholar 

  6. Koenig AM, Thase ME. First-line pharmacotherapies for depression: what is the best choice? Pol Arch Med Wewn 2009; 119(7–8): 478–85

    PubMed  CAS  Google Scholar 

  7. Dupuy JM, Ostacher MJ, Huffman J, et al. A critical review of pharmacotherapy for major depressive disorder. Int J Neuropsychopharmacol. Epub 2011 Feb 24

  8. Moret C, Isaac M, Briley M. Problems associated with long-term treatment with selective serotonin reuptake inhibitors. J Psychopharmacol 2009 Nov; 23(8): 967–74

    Article  PubMed  CAS  Google Scholar 

  9. Millan MJ. Dual- and triple-acting agents for treating core and co-morbid symptoms of major depression: novel concepts, new drugs. Neurotherapeutics 2009; 6(1): 53–77

    Article  PubMed  CAS  Google Scholar 

  10. Uppal A, Singh A, Gahtori P, et al. Antidepressants: current strategies and future opportunities. Curr Pharm Des 2010; 16(38): 4243–53

    Article  PubMed  CAS  Google Scholar 

  11. Whale R, Terao T, Cowen P, et al. Pindolol augmentation of serotonin reuptake inhibitors for the treatment of depressive disorder: a systemic review. J Psychopharmacol 2010 Apr; 24(4): 513–20

    Article  PubMed  CAS  Google Scholar 

  12. Preskorn SH, Ross R, Stanga CY. Selective serotonin re-uptake inhibitors. In: Preskorn SH, Feighner JP, Stanga CY, et al., editors. Antidepressants: past, present and future. Berlin, Heidelberg: Springer-Verlag, 2004: 241–62

    Chapter  Google Scholar 

  13. Blier P, Bergeron R. The use of pindolol to potentiate anti-depressant medication. J Clin Psychiatry 1998; 59 Suppl. 5: 16–23

    Google Scholar 

  14. Khan A. Vilazodone, a novel dual-acting serotonergic anti-depressant for managing major depression. Expert Opin Investig Drugs 2009 Nov; 18(11): 1753–64

    Article  PubMed  CAS  Google Scholar 

  15. Howland RH. Vilazodone. J Psychosoc Nurs Ment Health Serv 2011 Mar; 49(3): 19–22

    PubMed  Google Scholar 

  16. Rickels K, Athanasiou M, Reed C. Vilazodone, a novel, dual-acting antidepressant: current status, future promise and potential for individualized treatment of depression. Personalized Med 2009; 6(2): 217–24

    Article  CAS  Google Scholar 

  17. de Paulis T. Drug evaluation: vilazodone: a combined SSRI and 5HT1A partial agonist for the treatment of depression. Idrugs 2007 Mar; 10(3): 193–201

    PubMed  Google Scholar 

  18. Kalia R, Mittal MS, Preskorn SH. Vilazodone for major depressive disorder. Curr Psychiatry 2011 Apr; 10(4): 84–8

    Google Scholar 

  19. Viibryd™ (vilazodone hydrochloride) tablets: US prescribing information. St Louis (MO): Forest Pharmaceuticals Inc., 2011 Mar

  20. Ashby CR, Kehne JH, Bartoszyk GD, et al. Electro-physiological assessment of accelerated 5-HT1A auto-receptor desensitization in rats produced by vilazodone, a novel serotonin reuptake inhibitor and 5-HT1A receptor partial agonist. Biol Psychiatry 2010 May 1; 67 (9 Suppl. 1): 237-8S. Plus poster presented at the 65th Annual Meeting of the Society of Biological Psychiatry; 2010 May 20–22; New Orleans (LA)

  21. Kehne JH, Bartoszyk GD, Greiner HE, et al. In vivo and ex vivo characterization of vilazodone as a serotonin reuptake inhibitor and 5-HT1A receptor partial agonist [abstract]. Biol Psychiatry 2010 May 1; 67 (9 Suppl. 1): 238S. Plus poster presented at the 65th Annual Meeting of the Society of Biological Psychiatry; 2010 May 20–22; New Orleans (LA)

  22. Kehne JH, Bartoszyk GD, Greiner HE, et al. In vitro characterization of vilazodone as a dual-acting serotonin reuptake inhibitor and 5-HT1A receptor partial agonist [abstract]. Biol Psychiatry 2010 May 1; 67 (9 Suppl. 1): 237S. Plus poster presented at the 65th Annual Meeting of the Society of Biological Psychiatry; 2010 May 20–22; New Orleans (LA)

  23. Roberts C, Hagan JJ, Bartoszyk GD, et al. Effect of vilazodone on 5-HT efflux and re-uptake in the guinea-pig dorsal raphe nucleus. Eur J Pharmacol 2005 Jul 4; 517(1–2): 59–63

    Article  PubMed  CAS  Google Scholar 

  24. 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 Mar 7; 510(1–2): 49–57

    Article  PubMed  CAS  Google Scholar 

  25. 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-carb oxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine(1A) receptor partial agonist. J Pharmacol Exp Ther 2002 Sep; 302(3): 1220–7

    Article  PubMed  CAS  Google Scholar 

  26. Sorbera LA, Rabasseda X, Silvestre J, et al. Vilazodone hydrochloride. Drugs Future 2001; 26(3): 247–52

    Article  CAS  Google Scholar 

  27. Bartoszyk GD, Hegenbart R, Ziegler H. EMD 68843, a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties. Eur J Pharmacol 1997 Mar 19; 322(2–3): 147–53

    Article  PubMed  CAS  Google Scholar 

  28. Heinrich T, Bottcher H, Gericke R, et al. Synthesis and structure-activity relationship in a class of indole-butylpiperazines as dual 5-HT(1A) receptor agonists and serotonin reuptake inhibitors. J Med Chem 2004 Sep 9; 47(19): 4684–92

    Article  PubMed  CAS  Google Scholar 

  29. Treit D, Degroot A, Kashluba S. Systemic EMD 68843 injections reduce anxiety in the shock-probe, but not the plus-maze test. Eur J Pharmacol 2001 Mar 2; 414(2–3): 245–8

    Article  PubMed  CAS  Google Scholar 

  30. Morganroth J, Thorn MD, Gallipoli S. An evaluation of the effect of vilazodone on cardiac safety [abstract plus poster 3-176]. 45th American Society of Health-System Pharmacists Mid-Year Clinical Meeting; 2010 Dec 5–9; Anaheim (CA)

  31. 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. Nucl Med Biol 2000 Jul; 27(5): 509–13

    Article  PubMed  CAS  Google Scholar 

  32. Murck H, Frieboes RM, Antonijevic IA, et al. 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 May; 155(2): 187–92

    Article  CAS  Google Scholar 

  33. Center for Drug Evaluation and Research. Application number: 022567Orig1s 000. Summary review [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000SumR.pdf [Accessed 2011 Mar 18]

  34. Center for Drug Evaluation and Research. Application number: 022567Orig1s 000. Clinical pharmacology and biopharmaceutics review(s) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000ClinPharmR.pdf [Accessed 2011 Mar 18]

  35. Longstreth J, Adams MH, Sperry V, et al. Effect of gastric pH on the bioavailability of vilazodone in healthy subjects [abstract plus poster 5-120]. 45th American Society of Health-System Pharmacists Mid-Year Clinical Meeting; 2010 Dec 5–9; Anaheim (CA)

  36. Longstreth J, Alcorn H, Adams MH, et al. Vilazodone pharmacokinetics in subjects with mild to moderate hepatic impairment [abstract plus poster NR4-37]. 163rd Annual Meeting of the American Psychiatric Association; 2010 May 22–26; New Orleans (LA)

  37. Alcorn H, Longstreth J, Adams MH, et al. Vilazodone pharmacokinetics in subject with mild to moderate renal impairment [abstract plus poster NR4-33]. 163rd Annual Meeting of the American Psychiatric Association; 2010 May 22–26; New Orleans (LA)

  38. Rickels K, Athanasiou M, Robinson DS, et al. 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 Mar; 70(3): 326–33

    Article  PubMed  CAS  Google Scholar 

  39. 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): 441–7

    Article  PubMed  CAS  Google Scholar 

  40. Robinson D, Kajdasz D, Gallipoli S, et al. A 1-year open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder [abstract plus poster NR4-22]. 163rd Annual Meeting of the American Psychiatric Association; 2010 May 22–26; New Orleans (LA)

  41. Thase ME, Athanasiou MC, Kajdasz DK, et al. The efficacy profile of vilazodone, a novel, dual-acting serotonergic, antidepressant in the treatment of major depressive disorder [abstract plus poster 108]. 23rd US Psychiatric and Mental Health Congress Conference and Exhibition; 2010 Nov 18-21; Orlando (FL)

  42. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed (text revision). Washington, DC: American Psychiatric Association, 2000

    Google Scholar 

  43. Croft HA, Kajdasz DK, Whalen H, et al. Safety and tolerability profile of vilazodone in patients with MDD [abstract plus poster 107]. 23rd US Psychiatric and Mental Health Congress Conference and Exhibition; 2010 Nov 18–21; Orlando (FL)

  44. Clayton A, Gallipolli S, Reed CR. Minimal impact of vilazodone on sexual function during treatment of major depressive disorder [abstract plus poster 106]. 23rd US Psychiatric and Mental Health Congress Conference and Exhibition; 2010 Nov 18–21; Orlando (FL)

Download references

Acknowledgements

This manuscript was reviewed by: C. Dolder, School of Pharmacy, Wingate University, Wingate, NC, USA; R.H. Howland, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA; D.V. Iosifescu, Mount Sinai School of Medicine, New York, NY, USA; M.E. Thase, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    James E. Frampton

Authors
  1. James E. Frampton
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to James E. Frampton.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Frampton, J.E. Vilazodone. CNS Drugs 25, 615–627 (2011). https://doi.org/10.2165/11207550-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11207550-000000000-00000

Keywords

Search

Navigation