본문 바로가기
KERD
논문KCI 등재

Vilazodone for the Treatment of Major Depressive Disorder: Focusing on Its Clinical Studies and Mechanism of Action

이수정|한창수|배치운|Prakash S. Masand|Ashwin A Patkar|왕승민
대한신경정신의학회 (Korean Neuropsychiatric Association)|2015.04|PSYCHIATRY INVESTIGATION|제12권 제2호|pp. 155-163|DOI http://dx.doi.org/10.4306/pi.2015.12.2.155

1

조회

0

다운로드

3

인용

0

참고문헌

키워드

EfficacySafetyAntidepressantVilazodoneNovel mechanism
주제분류정신과학

초록

We tried to review and update clinical and preclinical studies evaluating vilazodone’s role as an antidepressant for patients with major depressive disorder (MDD). In terms of its mechanism of actions, we sought to elaborate them mainly through preclinical animal studies. A data search was conducted in November 1, 2013, using the key terms “vilazodone” or “Viibryd,” in PubMed and Medline databases. All published and unpublished studies are included and citations from publications were also reviewed for additional references. Five unpublished, phase-II and two pivotal published phase-III clinical trials with nearly identical design (8-week, double-blind, randomized, and placebo-controlled) investigated efficacy of vilazodone, were found for the treatment of patients with MDD. Two post-hoc studies and one long-term open study were also included. Data were thoroughly reviewed to incorporate the pharmacology, action mechanism, efficacy and safety for the vilazodone in the treatment of major depressive disorder. Vilazodone is an antidepressant with novel mechanism of action because its chemical structure is unrelated to conventional antidepressant, and it has a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist profile. Vilazodone is an effective and safe treatment option with its novel action mechanisms for patients with depression. Its putative benefits compared with other antidepressants must be thoroughly studied in adequately-powered and well-designed future clinical trials.

Abstract

We tried to review and update clinical and preclinical studies evaluating vilazodone’s role as an antidepressant for patients with major depressive disorder (MDD). In terms of its mechanism of actions, we sought to elaborate them mainly through preclinical animal studies. A data search was conducted in November 1, 2013, using the key terms “vilazodone” or “Viibryd,” in PubMed and Medline databases. All published and unpublished studies are included and citations from publications were also reviewed for additional references. Five unpublished, phase-II and two pivotal published phase-III clinical trials with nearly identical design (8-week, double-blind, randomized, and placebo-controlled) investigated efficacy of vilazodone, were found for the treatment of patients with MDD. Two post-hoc studies and one long-term open study were also included. Data were thoroughly reviewed to incorporate the pharmacology, action mechanism, efficacy and safety for the vilazodone in the treatment of major depressive disorder. Vilazodone is an antidepressant with novel mechanism of action because its chemical structure is unrelated to conventional antidepressant, and it has a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist profile. Vilazodone is an effective and safe treatment option with its novel action mechanisms for patients with depression. Its putative benefits compared with other antidepressants must be thoroughly studied in adequately-powered and well-designed future clinical trials.

참고문헌 (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, 29, pp.409~416 (2007)
  2. Kessler RC, "The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R)", JAMA, 289, pp.3095~3105 (2003)
  3. Kocsis JH, "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, 70, pp.354~361 (2009)
  4. Massart R, "Beyond the monoaminergic hypothesis: neuroplasticity and epigenetic changes in a transgenic mouse model of depression", Philos Trans R Soc Lond B Biol Sci, 367, pp.2485~2494 (2012)
  5. Bortolozzi A, "Novel Therapeutic strategies in major depression: focus on RNAi and ketamine", Curr Pharm Des, 20, pp.3848~3860 (2014)
  6. Malhi GS, "Pharmacological management of unipolar depression", Acta Psychiatr Scand, (443), pp.6~23 (2013)
  7. Trivedi MH, "Medication augmentation after the failure of SSRIs for depression", N Engl J Med, 354, pp.1243~1252 (2006)
  8. Blier P, Ward, "Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study", Am J Psychiatry, 167, pp.281~288 (2010)
  9. Taneja C, "Cost-effectiveness of adjunctive therapy with atypical antipsychotics for acute treatment of major depressive disorder", Ann Pharmacother, 46, pp.642~649 (2012)
  10. Barowsky J, "An evidence-based approach to augmentation and combination strategies for: treatment-resistant depression", Psychiatry (Edgmont), 3, pp.42~61 (2006)
  11. "Forest Pharmaceuticals I. Viibryd (Vilazodone) Prescribing Information" (2011)[URL]
  12. Hughes ZA, "Neurochemical evaluation of the novel 5-HT1A receptor partial agonist", serotonin reuptake inhibitor, vilazodone, 2005, pp.510, 49~57
  13. Jain R, "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, 30, pp.263~270 (2014)
  14. Khan A, "Vilazodone in the treatment of major depressive disorder: efficacy across symptoms and severity of depression", Int Clin Psychopharmacol, 29, pp.86~92 (2014)
  15. Khan A, "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, pp.441~447 (2011)
  16. Duxon MS, "Latency to paroxetine-induced anxiolysis in the rat is reduced by co-administration of the 5-HT(1A) receptor antagonist WAY100635", Br J Pharmacol, 130, pp.1713~1719 (2000)
  17. Hogg S, "Acceleration of onset of action in schedule-induced polydipsia: combinations of SSRI and 5-HT1A and 5-HT1B receptor antagonists", Pharmacol Biochem Behav, 77, pp.69~75 (2004)
  18. Lindsey WT, "Vilazodone for the treatment of depression", Ann Pharmacother, 45, pp.946~953 (2011)
  19. Boinpally R, "Pharmacokinetics of vilazodone in patients with mild or moderate renal impairment", Clin Drug Investig, 33, pp.199~206 (2013)
  20. "Vilazodone Drug Approval Package"[URL]
  21. Bartoszyk GD, "EMD 68843, a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties", Eur J Pharmacol, 322, pp.147~153 (1997)
  22. Sorbera LA, "Vilazodone hydrochloride. Antidepressant, 5-HT1A partial agonist, 5-HT reuptake inhibitor", Drug Future, 26, pp.247~252 (2001)
  23. Celada P, "Serotonin 5-HT1A receptors as targets for agents to treat psychiatric disorders: rationale and current status of research", CNS Drugs, 27, pp.703~716 (2013)
  24. Sprouse JS, "Electrophysiological responses of serotoninergic dorsal raphe neurons to 5-HT1A and 5-HT1B agonists", Synapse, 1, pp.3~9 (1987)
  25. Casanovas JM, "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, 122, pp.733~741 (1997)
  26. Lanfumey L, "Central 5-HT(1A) receptors: regional distribution and functional characteristics", Nucl Med Biol, 27, pp.429~435 (2000)
  27. Blier P, "Is there a role for 5-HT1A agonists in the treatment of depression?", Biol Psychiatry, 53, pp.193~203 (2003)
  28. Blier P, "Putative mechanisms of action of antidepressant drugs in affective and anxiety disorders and pain", J Psychiatry Neurosci, 26, pp.37~43 (2001)
  29. Bel N, "Chronic treatment with fluvoxamine increases extracellular serotonin in frontal cortex but not in raphe nuclei", Synapse, 15, pp.243~245 (1993)
  30. Celada P, "The therapeutic role of 5-HT1A and 5-HT2A receptors in depression", J Psychiatry Neurosci, 29, pp.252~265 (2004)
  31. Hjorth S, "Serotonin autoreceptor function and antidepressant drug action", J Psychopharmacol, 14, pp.177~185 (2000)
  32. Briley M, "Neurobiological mechanisms involved in antidepressant therapies", Clin Neuropharmacol, 16, pp.387~400 (1993)
  33. Starr KR, "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, 2007, pp.32, 2163~2172
  34. Hughes ZA, "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, 5-HT transport inhibitor SB-649915-B, pp.Psychopharmacology (Berl), 2007[DOI]
  35. Dawson LA, "Vilazodone: a 5-HT1A receptor agonist", serotonin transporter inhibitor for the treatment of affective disorders, 2009, pp.15, 107~117
  36. Wang SM, "A review of current evidence for vilazodone in major depressive disorder", Int J Psychiatry Clin Pract, 17, pp.160~169 (2013)
  37. -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, 1220~1227
  38. Ashby CR Jr, "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, 714, pp.359~365 (2013)
  39. Laughren TP, "Vilazodone: clinical basis for the US Food and Drug Administration’s approval of a new antidepressant", J Clin Psychiatry, 72, pp.1166~1173 (2011)
  40. Rickels K, "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, pp.326~333 (2009)
  41. Robinson DS, "A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder", J Clin Psychopharmacol, 31, pp.643~646 (2011)
  42. Khan A, "Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depression", Expert Opin Investig Drugs, 18, pp.1753~1764 (2009)
  43. Murck H, "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), 155, pp.187~192 (2001)
  44. Quattrochi JJ, "Dose-related suppression of REM sleep and PGO waves by the serotonin-1 agonist eltoprazine", Neuropsychopharmacology, 8, pp.7~13 (1993)
  45. Driver HS, "The influence of ipsapirone, a 5-HT1A agonist, on sleep patterns of healthy subjects", Psychopharmacology (Berl), 117, pp.186~192 (1995)
  46. Sharpley AL, "The effects of paroxetine and nefazodone on sleep: a placebo controlled trial", Psychopharmacology (Berl), 126, pp.50~54 (1996)
  47. Edwards J, "Vilazodone lacks proarrhythmogenic potential in healthy participants: a thorough ECG study", Int J Clin Pharmacol Ther, 51, pp.456~465 (2013)
  48. Le Poul E, "Early desensitization of somato-dendritic 5-HT1A autoreceptors in rats treated with fluoxetine or paroxetine", Naunyn Schmiedebergs Arch Pharmacol, 352, pp.141~148 (1995)
  49. Li Q, "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, 282, pp.1581~1590 (1997)
  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, 66, pp.356~368 (2012)
  51. Clayton AH, "The effect of vilazodone on sexual function during the treatment of major depressive disorder", J Sex Med, 10, pp.2465~2476 (2013)
  52. Serretti A, "Treatment-emergent sexual dysfunction related to antidepressants : a meta-analysis", J Clin Psychopharmacol, 29, pp.259~266 (2009)
  53. Carstairs SD, "Recurrent seizure activity in a child after acute vilazodone ingestion", Ann Emerg Med, 60, pp.819~820 (2012)
  54. Loane C, "Buspirone: what is it all about?", Brain Res, 1461, pp.111~118 (2012)
  55. Hoge EA, "Generalized anxiety disorder: diagnosis and treatment", BMJ, 345, pp.e7500~ (2012)
  56. Rush AJ, "Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report", Am J Psychiatry, 163, pp.1905~1917 (2006)
  57. Rush AJ, "STAR*D: revising conventional wisdom", CNS Drugs, 23, pp.627~647 (2009)

관련 논문AI추천

A Critical View on New and Future AntidepressantsAlessandro Serretti대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2024 · 제22권 제2호Additional Clinical Benefit of Agomelatine Treatment for Major Depressive Disorder in Naturalistic Treatment Setting박원명, 배치운, Ashwin A. Patkar, Changsu Han, Kyung Ho Lee, Prakash S. Masand, Soo-Jung Lee, Tae Sun Han대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2023 · 제21권 제3호Ketamine in Major Depressive Disorder: Mechanisms and Future Perspectives김용구, 신민철대한신경정신의학회 · PSYCHIATRY INVESTIGATION2020 · 제17권 제3호미래의 항우울제이민수, 사공정규대한생물치료정신의학회 · 생물치료정신의학2011 · 제17권 제2호Serum N-Desmethylcitalopram Concentrations are Associated with the Clinical Response to Citalopram of Patients with Major DepressionBerna Yucel, Canan Uluoglu, Gul Ozbey, Ismail Cuneyt Guzey, Nazan Cerit, Nevzat Yuksel, Nurdan Eren Bodur, Serap Erdogan Taycan, Tayyibe Arslan대한신경정신의학회 · PSYCHIATRY INVESTIGATION2018 · 제15권 제3호근거중심 한국형 우울증 약물학적 치료지침, 개정판(II) : 항우울제의 위약대비 효과, 항우울제간 효과차이 및 효과판정의 적정시점고영훈, 구재우, 박선철, 박용천, 백종우, 성승환, 심세훈, 오강섭, 원은수, 이강준, 이경민, 이문수, 이민수, 이화영, 전홍진, 최준호, 한규만, 한상우, 한창수, 함병주, 황태연대한신경정신의학회 · 신경정신의학2013 · 제52권 제5호

이 간행물의 다른 논문 (9건)

Childhood Exposure to Psychological Trauma and the Risk of Suicide Attempts: The Modulating Effect of Psychiatric Disorders박수빈, 전홍진, 조맹제, 성수정, 홍진표pp. 171-176The Relationship between Type D Personality and Heart Rate Variability in Community Mental Health Center Users황택근, 이문수, 임정숙, 조숙행, 강노을pp. 197-203A 2-Year Psychological Autopsy Study of Completed Suicides in the Athens Greater Area, GreeceIoannis Michopoulos, Christos Christodoulou, Lefteris Lykouras, Athanassios Douzenis, Filippos Koutsaftis, Antonios Paraschakispp. 212-217Validation of the Mood and Anxiety Symptom Questionnaire in Korean Adolescents김근향, 이슬아, 조선미pp. 218-226Increased Cognition Connectivity Network in Major Depression Disorder: A fMRI StudyZhiguo Wu, Mei-hui Qiu, Yi-feng Xu, Dai-hui Peng, Cao Li, Ting Shen, Chen Zhang, Jun Liu, Biao Wang, Wei-min Yangpp. 227-234
원문 보기