ABSTRACT
Objective: To evaluate the effectiveness and tolerability of vortioxetine at supratherapeutic dosages in patients with treatment-resistant depression.
Methods: A retrospective observational naturalistic study was conducted in 56 depressed patients resistant to standard care treatment from September 2020 to April 2021. Effectiveness of the vortioxetine treatments was evaluated through Clinical Global Impressions (CGI) score, comparing CGI values at the beginning (T0) of the vortioxetine treatment with CGI values at the earliest of these 2 time points (T1): (1) 8 weeks of treatment with supratherapeutic dosages and (2) day of vortioxetine discontinuation or daily dosage reduction to ≤ 20 mg due to side effects. The tolerability and safe of vortioxetine were also monitored.
Results: Fifty-six patients (32 females and 24 males, mean ± SD age of 51.1 ± 9.3 years) were included in the study. Thirty-seven patients received vortioxetine 30 mg/d, while 19 patients were treated with a 40-mg/d dosage. CGI scores significantly decreased (P < .001) in patients treated with 30 mg/d and 40 mg/d, respectively. No severe side effects were reported. Weight gain and nausea were the most common reported side effects. Nausea and limited efficacy were recorded as the most frequent reasons for vortioxetine dose reduction. None of the patients required vortioxetine discontinuation.
Conclusions: Supratherapeutic doses of vortioxetine were relatively well-tolerated and effective in patients with treatment-resistant depression.
Free Access: Please Log In
This content is completely free—but you need to be logged in to read the full article. If you already have an account, please log in below. Otherwise, register for free to unlock instant access.
References (26)
- Han K-M, De Berardis D, Fornaro M, et al. Differentiating between bipolar and unipolar depression in functional and structural MRI studies. Prog Neuropsychopharmacol Biol Psychiatry. 2019;91:20–27. PubMed CrossRef
- Kasper S, Frazer A. Editorial for treatment-resistant depression (TRD). Int J Neuropsychopharmacol. 2019;22(2):83–84. PubMed CrossRef
- Sinyor M, Schaffer A, Levitt A. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial: a review. Can J Psychiatry. 2010;55(3):126–135. PubMed CrossRef
- 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. PubMed CrossRef
- Gaynes BN, Warden D, Trivedi MH, et al. What did STAR*D teach us? results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009;60(11):1439–1445. PubMed CrossRef
- Bennabi D, Charpeaud T, Yrondi A, et al. Clinical guidelines for the management of treatment-resistant depression: French recommendations from experts, the French Association for Biological Psychiatry and Neuropsychopharmacology and the fondation FondaMental. BMC Psychiatry. 2019;19(1):262. PubMed CrossRef
- Thase ME, Rush AJ. When at first you don’t succeed: sequential strategies for antidepressant nonresponders. J Clin Psychiatry. 1997;58(suppl 13):23–29. PubMed
- Ionescu DF, Rosenbaum JF, Alpert JE. Pharmacological approaches to the challenge of treatment-resistant depression. Dialogues Clin Neurosci. 2015;17(2):111–126. PubMed CrossRef
- Fava M. Diagnosis and definition of treatment-resistant depression. Biol Psychiatry. 2003;53(8):649–659. PubMed CrossRef
- Rush AJ. STAR*D: what have we learned? Am J Psychiatry. 2007;164(2):201–204. PubMed CrossRef
- Adamo D, Pecoraro G, Aria M, et al. Vortioxetine in the treatment of mood disorders associated with burning mouth syndrome: results of an open-label, flexible-dose pilot study. Pain Med. 2020;21(1):185–194. PubMed
- 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. PubMed CrossRef
- Chen G, Lee R, Højer A-M, et al. Pharmacokinetic drug interactions involving vortioxetine (Lu AA21004): a multimodal antidepressant. Clin Drug Investig. 2013;33(10):727–736. PubMed CrossRef
- Sowa-Kućma M, Pańczyszyn-Trzewik P, Misztak P, et al. Vortioxetine: a review of the pharmacology and clinical profile of the novel antidepressant. Pharmacol Rep. 2017;69(4):595–601. PubMed CrossRef
- Spina E, Santoro V. Drug interactions with vortioxetine, a new multimodal antidepressant. Riv Psichiatr. 2015;50(5):210–215. PubMed
- Salagre E, Grande I, Solé B, et al. Vortioxetine: a new alternative for the treatment of major depressive disorder. Rev Psiquiatr Salud Ment (Engl Ed). 2018;11(1):48–59. PubMed CrossRef
- Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134(4):382–389. PubMed CrossRef
- Guy W. Clinical Global Impressions. ECDEU Assessment Manual for Psychopharmacology. DHEW Publication No. 76-338. Rockville, MD: National Institute of Mental Health; 1976:217–222.
- Alvarez E, Perez V, Dragheim M, et al. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012;15(5):589–600. PubMed CrossRef
- Thase ME, Mahableshwarkar AR, Dragheim M, et al. 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. PubMed CrossRef
- Katona CL, Katona CP. New generation multi-modal antidepressants: focus on vortioxetine for major depressive disorder. Neuropsychiatr Dis Treat. 2014;10:349–354. PubMed CrossRef
- Mahableshwarkar AR, Affinito J, Reines EH, et al. Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials. CNS Spectr. 2020;25(3):352–362. PubMed CrossRef
- Henigsberg N, Mahableshwarkar AR, Jacobsen P, et al. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012;73(7):953–959. PubMed CrossRef
- Citrome L. Vortioxetine 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. 2014;68(1):60–82. PubMed CrossRef
- 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. PubMed CrossRef
- Mazza MG, Rossetti A, Botti ER, et al. Vortioxetine overdose in a suicidal attempt: a case report. Medicine (Baltimore). 2018;97(25):e10788. PubMed CrossRef
Please sign in or purchase this PDF for $40.