References
- Otte C, Gold SM, Penninx BW., et al. Major depressive disorder. Nat Rev Dis Primers. 2016;2(1):16065. doi:10.1038/nrdp.2016.65
- Hong J, Vernon D, Kunovac J, Stahl S. Emerging drugs for the treatment of major depressive disorder. Expert Opin Emerg Drugs. 2022;27(3):263–275. doi:10.1080/14728214.2022.2117297
- Seedat S, Scott KM, Angermeyer MC, et al. Cross-national associations between gender and mental disorders in the World Health Organization World Mental Health Surveys. Arch Gen Psychiatry. 2009;66(7):785–795. doi:10.1001/archgenpsychiatry.2009.36
- Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–1259. doi:10.1016/S0140-6736(17)32154-2
- Whooley MA, Wong JM. Depression and cardiovascular disorders. Annu Rev Clin Psychol. 2013;9(1):327–354. doi:10.1146/annurev-clinpsy-050212-185526
- Penninx BW, Guralnik JM, Pahor M, et al. Chronically depressed mood and cancer risk in older persons. J Natl Cancer Inst. 1998;90(24):1888–1893. doi:10.1093/jnci/90.24.1888
- Guaiana G, Barbui C, Hotopf M. Amitriptyline for depression. Cochrane Database Syst Rev. 2007;3:CD004186. doi:10.1002/14651858.CD004186.pub2
- Gibb A, Deeks ED. Vortioxetine: first global approval. Drugs. 2014;74(1):135–145. doi:10.1007/s40265-013-0161-9
- Zhang J, Mathis MV, Sellers JW, et al. The US Food and Drug Administration’s perspective on the new antidepressant vortioxetine. J Clin Psychiatry. 2015;76(1):8–14. doi:10.4088/JCP.14r09164
- 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
- Mork A, Montezinho LP, Miller S, et al. Vortioxetine (Lu AA21004), a novel multimodal antidepressant, enhances memory in rats. Pharmacol Biochem Behav. 2013;105:41–50. doi:10.1016/j.pbb.2013.01.019
- Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012;26(11):1408–1416. doi:10.1177/0269881112441866
- Dubovsky SL. Pharmacokinetic evaluation of vortioxetine for the treatment of major depressive disorder. Expert Opin Drug Metab Toxicol. 2014;10(5):759–766. doi:10.1517/17425255.2014.904286
- Areberg J, Sogaard B, Hojer AM. The clinical pharmacokinetics of Lu AA21004 and its major metabolite in healthy young volunteers. Basic Clin Pharmacol Toxicol. 2012;111(3):198–205. doi:10.1111/j.1742-7843.2012.00886.x
- Matsuno K, Nakamura K, Aritomi Y, Nishimura A. Pharmacokinetics, safety, and tolerability of vortioxetine following single- and multiple-dose administration in healthy Japanese adults. Clin Pharmacol Drug Dev. 2018;7(3):319–331. doi:10.1002/cpdd.381
- US Food and Drug Administration. Clinical pharmacology and biopharmaceutics review(s). Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000ClinPharmR.pdf. Accessed June 28, 2013.
- European Medicines Agency. Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/mL product-specific bioequivalence guidance. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/vortioxetine-hydrobromide-immediate-release-tablets-5-mg-10-mg-15-mg-20-mg-vortioxetine-lactate-oral/mL-product-specific-bioequivalence-guidance_en.pdf. Accessed June 22, 2017.
- US Food and Drug Administration. Bioavailability and bioequivalence studies submitted in NDAs or INDs—general considerations; 2014. Available from: https://www.fda.gov/media/88254/download. Accessed September 27, 2023.
- European Medicines Agency. Guideline on the investigation of bioequivalence; 2014. Available from: https://www.gmp-compliance.org/files/guidemgr/2016_EMEA_Bioequivalence.pdf. Accessed September 27, 2023.
- Gadiko C, Tippabhotla SK, Thota S, Battula R, Khan SM, Vobalaboina V. A randomized, crossover, single-dose bioequivalence study of two extended-release tablets of donepezil 23 mg in healthy human volunteers under fasting and fed states. Sci Pharm. 2013;81(3):777–791. doi:10.3797/scipharm.1302-13
- Hvenegaard MG, Bang-Andersen B, Pedersen H, Jorgensen M, Puschl A, Dalgaard L. Identification of the cytochrome P450 and other enzymes involved in the in vitro oxidative metabolism of a novel antidepressant, Lu AA21004. Drug Metab Dispos. 2012;40(7):1357–1365. doi:10.1124/dmd.112.044610