Vortioxetine for major depressive disorder: a systematic review and meta-analysis of randomized controlled trials

Abstract

Abstract:

AIM: To systematically review the therapeutic efficacy and safety of vortioxetine in treating major depressive disorder(MDD) with an updated meta-analysis. METHODS: The databases of Pubmed and Clinical trials were searched to obtain the randomized controlled trials (RCTs) of vortioxetine in treating MDD. Data were synthesized using RevMan 5.3 software provided by the Cochrane Collaboration.RESULTS:Compared with placebo, 5 mg and 10 mg vortioxetine could significantly increase the Montgomery-sberg Depression Rating Scale（MADRS）mean changes (WMD=-2.59, P=0.002; WMD=-3.47, P=0.000 3), the responder rate (OR=1.76, P=0.006; OR=2.18, P=0.005) and the rate of overall adverse events (OR=1.28, P=0.008; OR=1.33, P=0.01), suggesting better effectiveness but higher rate of adverse event of vortioxetine. There were no statistically significant differences between vortioxetine (5 mg) and positive drug duloxetine (60 mg) on MADRS mean changes (P=0.43) and responder rate (P=0.10), while the rate of overall adverse events of 5 mg vortioxetine was much lower(OR=0.52, P<0.000 1) . CONCLUSION: Vortioxetine is effective and relatively safe for the treatment of MDD.

Key words: major depressive disorder, vortioxetine, randomized controlled trial, meta-analysis

CLC Number:

R311

CHEN Jiaren, CUI Yudi, TIAN Hao, WANG Hao. Vortioxetine for major depressive disorder: a systematic review and meta-analysis of randomized controlled trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(1): 52-59.

References

［1］王睿，黄树明. 抑郁症发病机制研究进展［J］. 医学研究生学报，2014，27(12): 1332-1336.
［2］秦娟娟，刘振华，梁艳，等. 5-羟色胺及其受体与抑郁症［J］. 国际药学研究杂志，2012，39(5): 409-413.
［3］赵桂平，刘文芳，张颖超，等. 抗抑郁新药沃替西汀的药理与临床研究［J］. 中国临床药理学杂志，2015，31(2)：143-145.
［4］Jain R, Mahableshwarkar AR, Jacobsen PL, et al. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder［J］. Int J Neuropsychopharmacol, 2013, 16: 313-321.
［5］Alvarez E, Perez V, Dragheim M. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder ［J］. Int J Neuropsychopharmacol, 2012, 15(5):589-600.
［6］Fu J, Chen Y. The efficacy and safety of 5 mg/d Vortioxetine compared to placebo for major depresseive disorder: A meta-analysis［J］. Psychopharmacol , 2015, 232(1):7-16.
［7］Meeker AS, Herink MC, Haxby DG, et al. The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis［J］. Syst Rev, 2015, 4:21.
［8］Katona C, Hansen T, Olsen CK. 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［J］. Int Clin Psychopharmacol, 2012, 27(4):215-223.
［9］Jacobsen PL, Mahableshwarkar AR, Serenko M. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder［J］. J Clin Psychiatry, 2015, 76(5):575-582.
［10］Henigsberg N, Mahableshwarkar AR, Jacobsen P. 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］. J Clin Psychiatry, 2012, 73(7):953-959.
［11］Baldwin DS, Loft H, Dragheim M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD)［J］. Eur Neuropsychopharmacol, 2012, 22(7):482-491.
［12］Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder［J］. Curr Med Res Opin, 2013, 29(3):217-226.
［13］Mahableshwarkar AR, Jacobsen PL, Serenko M. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder［J］. J Clin Psychiatry, 2015, 76(5):583-591.
［14］范宁，杨甫德. 抗抑郁新药沃替西汀［J］. 中国新药杂志，2014, 23(16):1874-1850.
［15］Berhan A, Barker A. Vortioxetine in the treatment of adult patients with major depressive disorder: a meta-analysis of randomized double-blind controlled trials［J］. BMC Psychiatry, 2014, 14:276.
［16］Pae CU, Wang SM, Han C, et al. Vortioxetine, a multimodal antidepressant for generalized anxiety disorder: A systematic review and meta-analysis［J］. J Psychiatry Res, 2015, 64:88-98.

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