152
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Vortioxetine in the treatment of major depressive disorder

&
Pages 79-89 | Published online: 04 Mar 2015

References

  • Sanchez C , AsinKE, ArtigasF. Vortioxetine, a novel antidepressant with multimodal activity: review of preclinical and clinical data. Pharmacol. Therapeut. doi:10.1016/j.pharmthera.07.001 ( Epub ahead of print).
  • Guilloux JP , Mendez-DavidI, PehrsonAet al. Antidepressant and anxiolytic potential of the multimodal antidepressant Vortioxetine (Lu AA21004) assessed by behavioural and neurogenesis outcomes in mice. Neuropharmacology73, 147e159 (2013).
  • Bang-Andersen B , RuhlandT, J⊘rgensenMet al. Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J. Med. Chem.54, 3206–3221 (2011).
  • Ballaz SJ , AkilH, WatsonSJ. The 5-HT7 receptor: role in novel object discrimination and relation to novelty-seeking behaviour. Neuroscience149, 192–202 (2007).
  • Westrich L , PerhsonA, ZhongHet al. In vitro and in vivo effects of the multimodal antidepressant vortioxetine (LuAA21004) at human and rat targets. Int. J. Psychiatry Clin. Pract.16(Suppl. 1), 47 (2012).
  • M⊘rk A , PehrsonA, BrennumLTet al. Pharmacological effects of Lu AA21004: a novel multimodal compound for the treatment of major depressive disorder. J. Pharmacol. Exp. Ther.340, 666–675 (2012).
  • Jensen JB , du JardinKG, SongDet al. Vortioxetine, but not escitalopram or duloxetine, reverses memory impairment induced by central 5-HT depletion in rats: evidence for direct 5-HT receptor modulation. Eur. Neuropsychopharmacol.24, 148–159 (2014).
  • Du Jardin KG , JensenJB, SanchezC, PehrsonAL. Vortioxetine dose-dependently reverses 5-HT depletion-induced deficits in spatial working and object recognition memory: a potential role for 5-HT1A receptor agonism and 5-HT3 receptor antagonism. Eur. Neuropsychopharmacol.24, 160–171 (2014).
  • Stenkrona P , HalldinC, LundbergJ. 5-HTT and 5-HT1A receptor occupancy of the novel substance vortioxetine (LuAA21004). A PET study in control subjects. Eur. Neuropsychopharmacol.23, 1190–1198 (2013).
  • Areberg J , Luntang-JensenM, S⊘gaardB, NilausenDØ. Occupancy of the serotonin transporter after administration of Lu AA21004 and its relation to plasma concentration in healthy subjects. Basic Clin. Pharmacol. Toxicol.110, 401–404 (2012).
  • Meyer JH , WilsonAA, SagratiSet al. Serotonin transporter occupancy of five selective serotonin reuptake inhibitors at different doses: an [11C]DASB positron emission tomography study. Am. J. Psychiatry161, 826–835 (2004).
  • Alvarez E , PerezV, DragheimM, LoftH, ArtigasF. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int. J. Neuropsychopharmacol.15, 589–600 (2012).
  • Baldwin DS , LoftH, DragheimM. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of vortioxetine in acute treatment of major depressive disorder. Eur. Neuropsychopharmacol.22, 482–491 (2012).
  • Henigsberg N , MahableshwarkarAR, JacobsenP, ChenY, ThaseME. 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. Psychiatry73, 953–959 (2012).
  • Areberg J , S⊘gaardB, H⊘jerAM. The clinical pharmacokinetics of Lu AA21004 and its major metabolite in healthy young volunteers. Basic Clin. Pharmacol. Toxicol.111, 198–205 (2012).
  • Hvenegaard MG , Bang-AndersenB, PedersenH, J⊘rgensenM, PüschlA, DalgaardL. Identification of the cytochrome P450 and other enzymes involved in the in vitro oxidative metabolism of a novel antidepressant, Lu AA21004. Drug Metab. Dispos.40, 1357–1365 (2012).
  • Uldam HK , JuhlM, PedersenH, DalgaardL. Biosynthesis and identification of an N-oxide/N-glucuronide metabolite and first synthesis of an N-O-glucuronide metabolite of Lu AA21004. Drug Metab. Disposition39, 2264–2274 (2011).
  • Chen G , LeeR, H⊘jerAM, BuchbjergJK, SerenkoM, ZhaoZ. Pharmacokinetic drug interactions involving vortioxetine (Lu AA21004), a multimodal antidepressant. Clin. Drug Investig.33, 727–736 (2013).
  • Khin NA , ChenY-F, YangY, YangP, LaughrenTP. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications. J. Clin. Psychiatry72, 464–472 (2011).
  • Lane P . Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches. Pharmaceut. Statist.7, 93–106 (2008).
  • Siddiqui O , HungHM, O’NeillR. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J. Biopharm. Stat.19, 227–246 (2009).
  • Mahableshwarkar AR , JacobsenPL, ChenY. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine versus placebo for 8 weeks in adults with major depressive disorder. Curr. Med. Res. Opin.29, 217–226 (2013).
  • Jain R , MahableshwarkarAR, JacobsenPL, ChenY, ThaseME. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int. J. Neuropsychopharmacol.16, 313–321 (2013).
  • Boulenger JP , LoftH, OlsenCK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int. Clin. Psychopharmacol.29, 138–149 (2013).
  • Mahableshwarkar AR , JacobsenPL, SerenkoM, ChenY, TrivediM. A duloxetine-referenced fixed dose study comparing efficacy and safety of 2 vortioxetine doses in the acute treatment of adult patients with MDD. Presented at: 166th Annual Meeting of the American Psychiatric Association (APA), San Francisco, CA, USA, 18–22 May 2013.
  • Mahableshwarkar A , JacobsenPL, SerenkoM, ChenY, TrivediM. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine (LuAA21004) in adults with major depressive disorder. Presented at: 166th Annual Meeting of the American Psychiatric Association (APA). San Francisco, CA, USA, 18–22 May 2013.
  • Jacobsen P , MahableshwarkarAR, SerenkoM, ChanS, TrivediM. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10mg and 20mg in adults with major depressive disorder. Presented at: 166th Annual Meeting of the American Psychiatric Association (APA). San Francisco, CA, USA, 18–22 May 2013.
  • Katona C , HansenT, OlsenCK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int. Clin. Psychopharmacol.27, 215–223 (2012).
  • McIntyre RS , LophavenS, OlsenCK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int. J. Neuropsychopharmacol.17, 1557–1567 (2014).
  • Montgomery SA , NielsenRZ, PoulsenLH, HäggströmL. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum. Psychopharmacol.29, 470–482 (2014).
  • Koesters M , GuaianaG, CiprianiA, BeckerT, BarbuiC. Agomelatine efficacy and acceptability revisited: systematic review and meta-analysis of published and unpublished randomised trials. Br. J. Psychiatry203, 179–187 (2013).
  • Taylor D , SparshattA, VarmaS, OlofinjanaO. Antidepressant efficacy of agomelatine: meta-analysis of published and unpublished studies. BMJ348, g1888 (2014).
  • Pae CU , WangSM, HanCet al. Vortioxetine: a meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder. J. Psychiatry Neurosci.39(6), 140120 (2014).
  • Llorca PM , LançonC, BrignoneMet al. Relative efficacy and tolerability of vortioxetine versus selected antidepressants by indirect comparisons of similar clinical studies. Curr. Med. Res. Opin.30(12), 2589–2606 (2014).
  • Baldwin DS , LoftH, JacobsenP, FloreaI. The efficacy of vortioxetine in treating patients with severe depression or with depression and high level of anxiety symptoms. Poster presented at: 27th ECNP Congress. Berlin, Germany, 18–21 October 2014 ( Poster).
  • Baldwin DS , HansenT, FloreaI. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr. Med. Res. Opin.28, 1717–1724 (2012).
  • Alam MY , JacobsenPL, ChenY, SerenkoM, MahableshwarkarAR. Safety, tolerability, and efficacy of vortioxetine (Lu AA21004) in major depressive disorder: results of an open-label, flexible-dose, 52-week extension study. Int. Clin. Psychopharmacol.29, 36–44 (2014).
  • Boulenger JP , LoftH, FloreaI. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J. Psychopharmacol.26, 1408–1416 (2012).
  • Baldwin DS , SerenkoM, PaloW, LophavenS, MatzJ. The safety and tolerability of vortioxetine (Lu AA21004) in the treatment of adults with major depressive disorder. Int. Clin. Psychiatry Clin. Pract.17(Suppl. 2), S16–S17 (2013).
  • Rosenbaum JF , FavaM, HoogSL, AscroftRC, KrebsWB. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol. Psychiatry44, 77–87 (1998).
  • Posner K , BrownGK, StanleyBet al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am. J. Psychiatry168, 1266–1277 (2011).
  • Baldwin DS , MahableshwarkarAR, ChronesL, PaloW, MatzJ. The safety and tolerability of vortioxetine in treating adults with major depressive disorder after 52weeks of open-label treatment. Poster presented at: 27th ECNP Congress. Berlin, Germany, 18–21 October 2014.
  • Garnock-Jones KP . Vortioxetine: a review of its use in major depressive disorder. CNS Drugs28, 855–874 (2014).
  • Bidzan L , MahableshwarkarAR, JacobsenP, YanM, SheehanDV. Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial. Eur. Neuropsychopharmacol.22, 847–857 (2012).
  • Rothschild AJ , MahableshwarkarAR, JacobsenP, YanM, SheehanDV. Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur. Neuropsychopharmacol.22, 858–866 (2012).
  • Mahableshwarkar AR , JacobsenPL, ChenY, SimonJS. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Int. J. Clin. Pract.68, 49–59 (2014).
  • Mahableshwarkar AR , JacobsenPL, Serenko, ChenY. A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 mg and 10 mg in acute treatment of adults with generalized anxiety disorder. Hum. Psychopharmacol.29, 64–72 (2014).
  • Baldwin DS , LoftH, FloreaI. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int. Clin. Psychopharmacol.27, 197–207 (2012).
  • 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 need to treat, number needed to harm, and likelihood to be helped or harmed?Int. J. Clin. Pract.68, 608–682 (2014).
  • Baldwin DS , FoongT. Antidepressant drugs and sexual dysfunction. Br. J Psychiatry202, 396–397 (2013).
  • McIntyre RS , ChaDS, SoczynskaJKet al. Cognitive deficits and functional outcomes in major depressive disorder: determinants, substrates and treatment interventions. Depress. Anx.30, 515–527 (2013).
  • Impey B , BaldwinDS. On ‘cognitive dysfunction’ as a novel target for antidepressant treatment. Hum. Psychopharmacol.28, 535–537 (2013).
  • Bora E , HarrisonBJ, YücelM, PantelisC. Cognitive impairment in euthymic major depressive disorder: a meta-analysis. Psychol. Med.43, 2017–2026 (2013).
  • Mork A , MontezhinoLP, MillerSet al. Vortioxetine (LuAA21004), a novel multimodal antidepressant, enhances memory in rats. Pharmacol. Biochem. Behav.105, 41–50 (2013).
  • Wallace A , PehrsonAL, SanchezC, MorilakDA. Vortioxetine restores learning impaired by 5-HT depletion or chronic intermittent cold stress in rats. Int. J. Neuropsychopharmacol.17, 1695–1706 (2014).
  • Theunissen EL , StreetD, H⊘jerAM, VermeerenA, van OersA, RamaekersJG. A randomized trial on the acute and steady-state effects of a new antidepressant, vortioxetine (Lu AA21004), on actual driving and cognition. Clin. Pharmacol. Ther.93, 493–501 (2013).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.