189
Views
1
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Effectiveness of Vortioxetine in Patients with Major Depressive Disorder in Real-World Clinical Practice in Italy: Results from the RELIEVE Study

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, & ORCID Icon show all
Pages 1665-1677 | Received 18 May 2022, Accepted 20 Jul 2022, Published online: 09 Aug 2022

References

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–1858. doi:10.1016/S0140-6736(18)32279-7
  • World Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017. Available from https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf. Accessed 18 May 2022.
  • Italian National Institute of Statistics (Istat). Mental health at various stages of life: years 2015–2017. Available from: https://www.istat.it/it/files//2018/07/Mental-health.pdf. Accessed 18 May 2022.
  • Fiorillo A, Sampogna G, Giallonardo V, et al. Effects of the lockdown on the mental health of the general population during the COVID-19 pandemic in Italy: results from the COMET collaborative network. Eur Psychiatry. 2020;63(1):e87. doi:10.1192/j.eurpsy.2020.89
  • Amerio A, Lugo A, Stival C, et al. COVID-19 lockdown impact on mental health in a large representative sample of Italian adults. J Affect Disord. 2021;292:398–404. doi:10.1016/j.jad.2021.05.117
  • Medda E, Toccaceli V, Gigantesco A, Picardi A, Fagnani C, Stazi MA. The COVID-19 pandemic in Italy: depressive symptoms immediately before and after the first lockdown. J Affect Disord. 2021;298(PtA):202–208. doi:10.1016/j.jad.2021.10.129
  • Lam RW, Parikh SV, Michalak EE, Dewa CS, Kennedy SH. Canadian Network for Mood and Anxiety Treatments (CANMAT) consensus recommendations for functional outcomes in major depressive disorder. Ann Clin Psychiatry. 2015;27(2):142–149.
  • IsHak WW, James DM, Mirocha J, et al. Patient-reported functioning in major depressive disorder. Ther Adv Chronic Dis. 2016;7(3):160–169. doi:10.1177/2040622316639769
  • Lam RW, McIntosh D, Wang J, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical guidelines for the management of adults with major depressive disorder: Section 1. Disease burden and principles of care. Can J Psychiatry. 2016;61(9):510–523. doi:10.1177/0706743716659416
  • Gonda X, Sharma SR, Tarazi FI. Vortioxetine: a novel antidepressant for the treatment of major depressive disorder. Expert Opin Drug Discov. 2019;14(1):81–89. doi:10.1080/17460441.2019.1546691
  • European Medicines Agency. Brintellix. Vortioxetine. Procedure No. EMEA/H/C/002717. Applicant: H. Lundbeck A/S. Assessment Report for an Initial Marketing Authorisation Application. Europe: European Medicines Agency; 2013.
  • Sanchez C, Asin KE, Artigas F. Vortioxetine, a novel antidepressant with multimodal activity: review of preclinical and clinical data. Pharmacol Ther. 2015;145:43–57. doi:10.1016/j.pharmthera.2014.07.001
  • Thase ME, Mahableshwarkar AR, Dragheim M, Loft H, Vieta E. A meta-analysis of randomized, placebo-controlled trials of vortioxetine for the treatment of major depressive disorder in adults. Eur Neuropsychopharmacol. 2016;26(6):979–993. doi:10.1016/j.euroneuro.2016.03.007
  • Baldwin DS, Florea I, Jacobsen PL, Zhong W, Nomikos GG. A meta-analysis of the efficacy of vortioxetine in patients with major depressive disorder (MDD) and high levels of anxiety symptoms. J Affect Disord. 2016;206:140–150. doi:10.1016/j.jad.2016.07.015
  • McIntyre RS, Harrison J, Loft H, Jacobson W, Olsen CK. The effects of vortioxetine on cognitive function in patients with major depressive disorder: a meta-analysis of three randomized controlled trials. Int J Neuropsychopharmacol. 2016;19(10):pyw055. doi:10.1093/ijnp/pyw055
  • Florea I, Loft H, Danchenko N, et al. The effect of vortioxetine on overall patient functioning in patients with major depressive disorder. Brain Behav. 2017;7(3):e00622. doi:10.1002/brb3.622
  • Christensen MC, Florea I, Lindsten A, Baldwin DS. Efficacy of vortioxetine on the physical symptoms of major depressive disorder. J Psychopharmacol. 2018;32(10):1086–1097. doi:10.1177/0269881118788826
  • Christensen MC, McIntyre RS, Florea I, Loft H, Fagiolini A. Vortioxetine 20 mg/day in patients with major depressive disorder: updated analysis of efficacy, safety, and optimal timing of dose adjustment. CNS Spectr. 2021;18:1–26. doi:10.1017/S1092852921000936
  • Iovieno N, Papakostas GI, Feeney A, et al. Vortioxetine versus placebo for major depressive disorder: a comprehensive analysis of the clinical trial dataset. J Clin Psychiatry. 2021;82(4):20r13682. doi:10.4088/JCP.20r13682
  • McIntyre RS, Loft H, Christensen MC. Efficacy of vortioxetine on anhedonia: results from a pooled analysis of short-term studies in patients with major depressive disorder. Neuropsychiatr Dis Treat. 2021;17:575–585. doi:10.2147/NDT.S296451
  • Mattingly GW, Ren H, Christensen MC, et al. Effectiveness of vortioxetine in patients with major depressive disorder in real-world clinical practice: results of the RELIEVE study. Front Psychiatry. 2022;13:824831. doi:10.3389/fpsyt.2022.824831
  • American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
  • Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(Suppl 3):89–95. doi:10.1097/00004850-199606003-00015
  • Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol. 2008;23(2):70–83. doi:10.1097/YIC.0b013e3282f2b4d6
  • Sheehan DV, Harnett‐Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol. 2011;26(2):75–83. doi:10.1097/YIC.0b013e328341bb5f
  • Kroenke K, Spitzer RL, Williams JB, The PHQ-9. validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–613. doi:10.1046/j.1525-1497.2001.016009606.x
  • Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. Rockville: US Department of Health, Education, and Welfare (Alcohol, Drug Abuse, and Mental Health Administration); 1976.
  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry. 2007;4(7):28–37.
  • Lam RW, Lamy FX, Danchenko N, et al. Psychometric validation of the Perceived Deficits Questionnaire-Depression (PDQ-D) instrument in US and UK respondents with major depressive disorder. Neuropsychiatr Dis Treat. 2018;14:2861–2877. doi:10.2147/NDT.S175188
  • Fehnel SE, Forsyth BH, Dibenedetti DB, Danchenko N, François C, Brevig T. Patient-centered assessment of cognitive symptoms of depression. CNS Spectr. 2016;21(1):43–52. doi:10.1017/S1092852913000643
  • Wechsler D. Manual for the Wechsler Adult Intelligence Scale—Revised. New York: Psychological Corporation; 1981.
  • 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. doi:10.1080/009262300278623
  • EuroQol Research Foundation. EQ-5D-5L User Guide. Version 3.0. EuroQol Research Foundation, Rotterdam; 2019. Available from https://euroqol.org/publications/user-guides. Accessed 18 May 2022.
  • R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing; 2016. Available from http://www.R-project.org/. Accessed 18 May 2022.
  • Kennedy SH, Lam RW, McIntyre RS, et al.; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 3. Pharmacological Treatments. Can J Psychiatry. 2016;61(9):540–560. doi:10.1177/0706743716659417
  • Baldwin DS, Manson C, Nowak M. Impact of antidepressant drugs on sexual function and satisfaction. CNS Drugs. 2015;29(11):905–913. doi:10.1007/s40263-015-0294-3
  • Atmaca M. Selective serotonin reuptake inhibitor-induced sexual dysfunction: current management perspectives. Neuropsychiatr Dis Treat. 2020;16:1043–1050. doi:10.2147/NDT.S185757
  • Baldwin DS, Chrones L, Florea I, et al. The safety and tolerability of vortioxetine: analysis of data from randomized placebo-controlled trials and open-label extension studies. J Psychopharmacol. 2016;30(3):242–252. doi:10.1177/0269881116628440
  • Uguz F, Sahingoz M, Gungor B, Aksoy F, Askin R. Weight gain and associated factors in patients using newer antidepressant drugs. Gen Hosp Psychiatry. 2015;37(1):46–48. doi:10.1016/j.genhosppsych.2014.10.011
  • Chin CN, Zain A, Hemrungrojn S, et al. Results of a real-world study on vortioxetine in patients with major depressive disorder in South East Asia (REVIDA). Curr Med Res Opin. 2018;34(11):1975–1984. doi:10.1080/03007995.2018.1477746
  • Chokka P, Bougie J, Proulx J, Tvistholm AH, Ettrup A. Long-term functioning outcomes are predicted by cognitive symptoms in working patients with major depressive disorder treated with vortioxetine: results from the AtWoRC study. CNS Spectr. 2019;24(6):616–627. doi:10.1017/S1092852919000786
  • Fagiolini A, Florea I, Loft H, Christensen MC. Effectiveness of vortioxetine on emotional blunting in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment. J Affect Disord. 2021;283:472–479. doi:10.1016/j.jad.2020.11.106
  • Yang YK, Chen CS, Tsai CF, et al. A Taiwanese study on real-world evidence with vortioxetine in patients with major depression in Asia (TREVIDA). Curr Med Res Opin. 2021;37(12):2163–2173. doi:10.1080/03007995.2021.1980869
  • Papalexi E, Galanopoulos A, Kontis D, et al. Real-world effectiveness of vortioxetine in outpatients with major depressive disorder: functioning and dose effects. BMC Psychiatry. In Press 2022.
  • Baune BT, Sluth LB, Olsen CK. The effects of vortioxetine on cognitive performance in working patients with major depressive disorder: a short-term, randomized, double-blind, exploratory study. J Affect Disord. 2018;229:421–428. doi:10.1016/j.jad.2017.12.056
  • McIntyre RS, Lophaven S, Olsen CK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol. 2014;17(10):1557–1567. doi:10.1017/S1461145714000546
  • Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RS. A randomized, placebo-controlled, active-reference, double-blind, flexible-dose study of the efficacy of vortioxetine on cognitive function in major depressive disorder. Neuropsychopharmacology. 2015;40:2025–2037. doi:10.1038/npp.2015.52
  • McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of vortioxetine on cognitive functioning in working patients with major depressive disorder. J Clin Psychiatry. 2017;78(1):115–121. doi:10.4088/JCP.16m10744
  • Vieta E, Sluth LB, Olsen CK. The effects of vortioxetine on cognitive dysfunction in patients with inadequate response to current antidepressants in major depressive disorder: a short-term, randomized, double-blind, exploratory study versus escitalopram. J Affect Disord. 2018;227:803–809. doi:10.1016/j.jad.2017.11.053
  • Murman DL. The impact of age on cognition. Semin Hear. 2015;36(3):111–121. doi:10.1055/s-0035-1555115
  • Cournot M, Marquié JC, Ansiau D, et al. Relation between body mass index and cognitive function in healthy middle-aged men and women. Neurology. 2006;67(7):1208–1214. doi:10.1212/01.wnl.0000238082.13860.50
  • Dye L, Boyle NB, Champ C, Lawton C. The relationship between obesity and cognitive health and decline. Proc Nutr Soc. 2017;76(4):443–454. doi:10.1017/S0029665117002014
  • Zhou Y, Zhang T, Lee D, Yang L, Li S. Body mass index across adult life and cognitive function in the American elderly. Aging. 2020;12(10):9344–9353. doi:10.18632/aging.103209
  • Kessler RC, Sampson NA, Berglund P, et al. Anxious and non-anxious major depressive disorder in the World Health Organization World Mental Health Surveys. Epidemiol Psychiatr Sci. 2015;24(3):210–226. doi:10.1017/S2045796015000189
  • Dold M, Bartova L, Souery D, et al. Clinical characteristics and treatment outcomes of patients with major depressive disorder and comorbid anxiety disorders – results from a European multicenter study. J Psychiatr Res. 2017;91:1–13. doi:10.1016/j.jpsychires.2017.02.020
  • Gaspersz R, Nawijn L, Lamers F, Penninx BWJH. Patients with anxious depression: overview of prevalence, pathophysiology and impact on course and treatment outcome. Curr Opin Psychiatry. 2018;31(1):17–25. doi:10.1097/YCO.0000000000000376
  • 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. doi:10.1176/appi.ajp.2007.06111868
  • Saveanu R, Etkin A, Duchemin AM, et al. The international Study to Predict Optimized Treatment in Depression (iSPOT-D): outcomes from the acute phase of antidepressant treatment. J Psychiatr Res. 2015;61:1–12. doi:10.1016/j.jpsychires.2014.12.018
  • Bidzan L, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial. Eur Neuropsychopharmacol. 2012;22(12):847–857. doi:10.1016/j.euroneuro.2012.07.012
  • Liebowitz MR, Careri J, Blatt K, et al. Vortioxetine versus placebo in major depressive disorder comorbid with social anxiety disorder. Depress Anxiety. 2017;34(12):1164–1172. doi:10.1002/da.22702
  • Christensen MC, Schmidt S, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: results of the open-label RECONNECT study. J Psychopharmacol. 2022;36(5):566–577. doi:10.1177/02698811221090627
  • Italian National Institute of Statistics (Istat). Households and population projections: 1/1/2020. Available from: https://www.istat.it/it/files//2021/11/Households-and-population-projections.pdf. Accessed 18 May 2022.
  • IsHak WW, Mirocha J, Pi S, et al. Patient-reported outcomes before and after treatment of major depressive disorder. Dialogues Clin Neurosci. 2014;16(2):171–183. doi:10.31887/DCNS.2014.16.2/rcohen
  • Demyttenaere K, Donneau AF, Albert A, Ansseau M, Constant E, van Heeringen K. What is important in being cured from depression? Discordance between physicians and patients. J Affect Disord. 2015;174:390–396. doi:10.1016/j.jad.2014.12.004
  • Baune BT, Christensen MC. Differences in perceptions of major depressive disorder symptoms and treatment priorities between patients and health care providers across the acute, post-acute, and remission phases of depression. Front Psychiatry. 2019;10:335. doi:10.3389/fpsyt.2019.00335
  • Christensen MC, Wong CMJ, Baune BT. Symptoms of major depressive disorder and their impact on psychosocial functioning in the different phases of the disease: do the perspectives of patients and healthcare providers differ? Front Psychiatry. 2020;11:280. doi:10.3389/fpsyt.2020.00280