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Vortioxetine (, trade name Brintellix () and Trintellix in Canada) is an atypical antidepressant (a serotonin modulator and stimulator) made by Lundbeck and Takeda.〔"(BRINTELLIX™ (vortioxetine) tablets for oral use. Full Prescribing Information, Section 12.2 (Pharmacodynamics). )" Takeda Pharmaceuticals America Inc. and Lundbeck, 2013. Revised September 2013.〕 On September 30, 2013, it was approved by the U.S. FDA for the treatment of major depressive disorder (MDD) in adults.〔(FDA approves new drug to treat major depressive disorder ), U.S. Food and Drug Administration Press Announcement.〕 Vortioxetine was also investigated as a treatment for generalized anxiety disorder (GAD) but was not found to be superior to placebo. Following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in October 2013,〔http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002717/smops/Positive/human_smop_000601.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human〕 Lundbeck announced December 27, 2013, that European marketing authorization for Brintellix had been obtained.〔Lundbeck press release (December 27, 2013): Lundbeck receives European marketing authorization for Brintellix for the treatment of adults with Major Depressive Episodes ()〕 ==Depression== In May 22, 2011, Lundbeck presented the results of four phase III trials on vortioxetine at the 2011 Annual Meeting of the American Psychiatric Association. A statistically significant effect was shown in two of the studies (one for active treatment using the Hamilton Depression Rating Scale (HAM-D), the second as a maintenance treatment), vortioxetine failed to prove superiority over placebo in a third (again using the HAM-D) and the fourth was nullified by an exceptionally high placebo response (according to the Montgomery-Åsberg Depression Rating Scale (MADRS)).〔http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=608559〕 In July 2011, Lundbeck published the results of a double-blind, randomized, placebo-controlled clinical trial with venlafaxine as an active reference. It was found to be superior to placebo in treating MDD. Similarly, in May 2012, Lundbeck published the results of a double-blind, randomized, placebo-controlled clinical trial with duloxetine evaluating vortioxetine in elderly depressed patients, and it was found superior to placebo. In May 2012, Lundbeck disclosed the results of three phase III clinical trials, showing vortioxetine's superiority over placebo according to the MADRS.〔http://www.fiercebiotech.com/press-releases/statistically-significant-clinical-phase-iii-results-lu-aa21004-provide-bas〕 In August 2012, a randomized, double-blind trial confirms the superiority of vortioxetine over placebo according to all measures, except the Sheehan Disability scale. In September 2012, a randomised, double-blind trial reveals that a dose of 5 mg shows superiority over placebo only in patients that suffer from comorbid anxiety. This is consistent with results from another trial published in December 2012, demonstrating that 2.5 mg and 5 mg doses are ineffective. Some 2014 studies showed Vortioxetine was effective and well tolerated after inadequate response to SSRI/SNRI, as initial agent up to 20 mg, and as maintenance use lasting 52 weeks. A 2014 Meta-analysis of 7 randomized trials concluded Vortioxetine had significant reductions vs placebo in depression scores and patients with 50% reduction. Vortioxetine was ranked among 7 antidepressants with different mechanisms, placing vortioxetine greater efficacy than escitalopram, vilazodone, and sertraline with better tolerability, concluding that Vortioxetine has a favorable combination of comparable effect and excellent tolerability. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Vortioxetine」の詳細全文を読む スポンサード リンク
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