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更新于：2025-11-25
Vortioxetine Hydrobromide
氢溴酸伏硫西汀
更新于：2025-11-25
概要
基本信息
药物类型 小分子化药 |
别名 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine monohydrobromide、VORTIOXETINE、Vortioxetine hydrobromide (JAN/USAN) + [17] |
作用方式 激动剂、拮抗剂、抑制剂 |
作用机制 5-HT1A receptor激动剂(5-羟色胺1A受体激动剂)、5-HT1B receptor激动剂(5-羟色胺1B受体激动剂)、5-HT1D receptor拮抗剂(5-羟色胺1D受体拮抗剂) |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2013-09-30), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C18H23BrN2S |
InChIKeyVNGRUFUIHGGOOM-UHFFFAOYSA-N |
CAS号960203-27-4 |
关联
180
项与 氢溴酸伏硫西汀 相关的临床试验NCT07204314
A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Administration of Vortioxetine in Japanese Pediatric Patients 12 to 17 Years of Age With Major Depressive Disorder (MDD)
TCTR20250108005
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vortioxetine Film-coated Tablet 10 mg relative to Brintellix 10 mg in healthy Thai volunteers under fasting condition
CTRI/2024/09/073258
To assess the safety, effectiveness and utility of vortioxetine as initial line therapy in the Management of depression through an observational, multicenter Study - IMPRESS
100 项与 氢溴酸伏硫西汀 相关的临床结果
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100 项与 氢溴酸伏硫西汀 相关的转化医学
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100 项与 氢溴酸伏硫西汀 相关的专利（医药）
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1,010
项与 氢溴酸伏硫西汀 相关的文献（医药）2026-02-01JOURNAL OF AFFECTIVE DISORDERS
Retrospective multicenter cohort study of slow titration of vortioxetine to mitigate early nausea in major depression
Article
作者: Menculini, Giulia ; De Berardis, Domenico ; Pinzi, Mario ; Libri, Claudia ; Pardossi, Simone ; Rescalli, Beatrice ; Caldiroli, Alice ; Carmellini, Pietro ; Clerici, Massimo ; Cuomo, Alessandro ; Trovini, Giada ; Fagiolini, Andrea ; Aguglia, Andrea ; Tortorella, Alfonso ; Koukouna, Despoina ; De Filippis, Sergio ; Bondi, Emi
BACKGROUND:
Vortioxetine, a multimodal antidepressant, has been extensively documented for its efficacy and safety. The medication is typically well tolerated, with nausea being the most common adverse effect. Gradual titration with the oral solution may further enhance the medication's tolerability.
METHODS:
This retrospective, uncontrolled multicenter study evaluated 188 adult patients with major depressive disorder (MDD) who were treated with vortioxetine oral drop solutions. Patients initiated treatment with vortioxetine at a dosage of one or two drops per day (equivalent to 1 mg or 2 mg, respectively) and underwent a gradual increase in dosage, with each subsequent dose increased by one or two drops, up to the target dose. The subjects were observed for a minimum of eight weeks. The primary objective was to assess tolerability, with particular attention paid to the incidence and progression of nausea. The efficacy of the treatment was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale at the outset of the study and at weeks 1, 2, 4, and 8. Adverse events were recorded through patient reports at weeks 1, 2, 4, and 8 and documented by clinicians.
RESULTS:
The administration of vortioxetine following a slow titration treatment protocol was found to markedly reduce the prevalence of nausea observed in 9.6 % of patients at week 1, 5.9 % at week 2, 2.7 % at week 4, and 1.7 % at week 8. The incidence of other adverse events exhibited a comparable decline over time. Despite the gradual dosing approach, patients exhibited a progressive improvement in their clinical status, as evidenced by a reduction in MADRS scores from a mean of 29.22 (SD 7.71) at baseline to 11.89 (SD 6.35) at week 8. At the end of the treatment period, 72 % of patients were classified as good responders for MADRS and 71 % for CGI (change ≥50 %) while 46 % achieved remission according to MADRS criteria (MADRS ≤10).
CONCLUSIONS:
In our cohort, the slow titration of vortioxetine oral drop solutions resulted in an enhancement in tolerability, accompanied by a decline in nausea compared to the rates documented in prior studies utilizing standard tablet formulations. This approach did not compromise the efficacy of the treatment. This flexible titration strategy represents a promising approach to the mitigation of adverse effects while maintaining clinical effectiveness. Further research should be conducted to investigate the long-term benefits of this method and to compare it to other titration protocols.
2025-12-01JOURNAL OF MOLECULAR HISTOLOGY
Vortioxetine protects against methotrexate-induced ovarian toxicity through anti-inflammatory, antioxidant and antiapoptotic pathways: a multi-marker immunohistochemical study
Article
作者: Ozcan, Kadriye Nilay ; Sarman, Emine ; Nazıroglu, Irem ; Asci, Halil ; Kolay, Oznur
AIMS:
Methotrexate (MTX), a commonly used chemotherapeutic and immunosuppressive agent, is known to induce significant ovarian toxicity through mechanisms involving oxidative stress, inflammation, and apoptosis. Vortioxetine (VTX), a novel antidepressant with proven neuroprotective and anti-inflammatory properties, has not yet been evaluated in the context of chemotherapy-induced gonadotoxicity. This study aimed to investigate the protective effects of VTX against MTX-induced ovarian injury in a rat model by employing comprehensive histopathological and immunohistochemical evaluations.
METHODS AND RESULTS:
Thirty-two adult female Wistar Albino rats (300-350 g) were randomly divided into four equal groups (n = 8): Control, MTX, MTX + VTX, and VTX. Ovarian damage was induced with a single intraperitoneal injection of MTX (20 mg/kg), while VTX was administered daily (10 mg/kg) by oral gavage for five days. Rats were sacrificed on day 5, and bilateral ovaries were collected. Histopathological evaluation included follicular degeneration, vascular congestion, hemorrhage, and inflammatory cell infiltration. Immunohistochemical analyses were performed for 8-Hydroxy-2'-deoxyguanosine (8-OHdG), nuclear factor kappa B (NF-κB), tumor necrosis factor-alpha (TNF-α), caspase 3 (Cas-3), and Anti-Müllerian hormone (AMH) to assess oxidative stress, inflammation, apoptosis, and ovarian reserve. MTX administration caused severe follicular atresia, hemorrhage, and dense neutrophil infiltration. Immunohistochemically, 8-OHdG, NF-κB, TNF-α, and Cas-3 expressions were significantly elevated, while AMH was markedly reduced. VTX co-treatment significantly attenuated histological damage and modulated the expression of all biomarkers, indicating potent protective effects. VTX alone did not induce deleterious changes.
CONCLUSION:
VTX exhibits a robust protective effect against MTX-induced ovarian injury via suppression of oxidative stress, inflammatory response and apoptotic pathways, while simultaneously preserving ovarian reserve. These findings highlight a novel application for VTX in fertility preservation strategies during chemotherapeutic interventions.
2025-12-01PSYCHIATRY RESEARCH
Investigation of the effects of vortioxetine and duloxetine on cognitive functions in major depressive disorder: an 8-week prospective study
作者: Çoban, Cansu ; Bulut, Süheyla Doğan
BACKGROUND:
Major depressive disorder (MDD) is a prevalent psychiatric condition characterized by cognitive deficits-including impairments in attention, memory, and executive functions-that persist during both acute episodes and remission. These cognitive deficits contribute to significant functional impairment and increase the risk of relapse. This study aimed to investigate the effects of duloxetine and vortioxetine, two antidepressants with distinct mechanisms of action, on cognitive functions in patients with MDD.
METHODS:
In this 8-week prospective study, 103 participants were enrolled: 35 patients with MDD treated with vortioxetine (10-20 mg), 34 with duloxetine (60-90 mg), and 34 healthy controls. Depressive symptom severity and clinical features were assessed using the Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and Clinical Global Impression Scale. Cognitive functions were evaluated with the Stroop TBAG form, Trail Making Test, and Auditory Verbal Learning Test.
RESULTS:
During the acute phase, patients with MDD performed significantly worse than healthy controls on tests of attention, processing speed, memory, and executive functions. After eight weeks of treatment, cognitive functions improved in both the duloxetine and vortioxetine groups. Vortioxetine was associated with greater improvements in selective and sustained attention and executive functions compared to duloxetine.
CONCLUSION:
Residual symptoms persisting during remission may be attributable to ongoing cognitive deficits. Addressing cognitive dysfunction is crucial for restoring functional capacity and preventing relapse in MDD. Further research with larger sample sizes is warranted to inform optimal treatment strategies.
100 项与 氢溴酸伏硫西汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 抑郁症 | 中国 | 2017-11-21 | |
| 重度抑郁症 | 美国 | 2013-09-30 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 创伤性脑损伤 | 临床3期 | - | 2016-10-01 | |
| 中度重度抑郁症 | 临床3期 | 中国 | 2012-09-13 | |
| 认知功能障碍 | 临床3期 | - | 2011-12-01 | |
| 性功能障碍 | 临床3期 | 美国 | 2011-06-01 | |
| 性功能障碍 | 临床3期 | 加拿大 | 2011-06-01 | |
| 广泛性焦虑障碍 | 临床3期 | 美国 | 2008-06-01 | |
| 广泛性焦虑障碍 | 临床3期 | 美国 | 2008-06-01 | |
| 额颞痴呆 | 临床2期 | 美国 | 2025-03-20 | |
| 躁郁症 | 临床2期 | 美国 | 2018-08-08 | |
| 躁郁症1型 | 临床2期 | 美国 | 2018-08-08 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 540 | 觸壓鹽繭窪壓膚艱壓鏇(餘窪糧夢齋製顧獵壓窪) = 觸選糧襯鹹壓觸齋顧餘 鹽衊膚廠蓋築範齋鏇鏇 (襯襯簾蓋選獵糧鬱積製, 1.2) 更多 | 不佳 | 2025-09-01 | |||
觸壓鹽繭窪壓膚艱壓鏇(餘窪糧夢齋製顧獵壓窪) = 淵構構簾製簾獵鹽網鏇 鹽衊膚廠蓋築範齋鏇鏇 (襯襯簾蓋選獵糧鬱積製, 1.4) 更多 | |||||||
临床3期 | 302 | 觸範廠鹽鏇獵鏇憲範糧(廠獵鑰餘鹹簾衊觸艱鑰) = 顧顧艱餘夢選壓齋廠遞 積築網構淵構鹹鹽鑰憲 (構製艱遞夢鑰簾鏇鬱簾, 10.6) 更多 | 不佳 | 2025-08-01 | |||
觸範廠鹽鏇獵鏇憲範糧(廠獵鑰餘鹹簾衊觸艱鑰) = 餘窪鬱壓淵鹽膚製願製 積築網構淵構鹹鹽鑰憲 (構製艱遞夢鑰簾鏇鬱簾, 11.6) 更多 | |||||||
临床2期 | 149 | (Vortioxetine) | 網遞網簾觸範膚觸餘觸(窪築築簾遞齋簾選壓糧) = 蓋觸廠壓壓鬱襯淵鬱廠 顧淵獵餘簾壓網糧簾顧 (顧構鑰獵壓積醖鏇繭蓋, 0.0752) 更多 | - | 2025-01-16 | ||
Placebo (Placebo) | 網遞網簾觸範膚觸餘觸(窪築築簾遞齋簾選壓糧) = 醖築餘窪獵鬱醖積觸製 顧淵獵餘簾壓網糧簾顧 (顧構鑰獵壓積醖鏇繭蓋, 0.0934) 更多 | ||||||
临床4期 | 395 | 鹹願構襯獵餘鏇醖鹽鑰(鹹糧構遞構鬱鹽鹽鬱襯) = 35.4% (n = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, n = 26 each) 壓鹹遞淵壓艱獵鬱築簾 (窪選製繭選選網窪蓋膚 ) | 积极 | 2024-08-07 | |||
N/A | 130 | 鹹襯遞構鹽壓鹹網遞選(壓遞淵糧膚鬱網鑰鑰遞) = 簾夢積觸鹽齋選獵醖鬱 鬱憲積選餘範憲獵積廠 (憲鑰獵齋鹽艱鹹淵夢憲 ) 更多 | 积极 | 2024-07-01 | |||
临床4期 | 605 | 構艱願構簾網壓選衊鹽(窪鏇顧構醖獵簾窪蓋範) = TEAEs were reported in 46.1% and 39.6% of patients in the vortioxetine and desvenlafaxine groups, respectively; these were mostly mild or moderate in intensity (> 98% of all TEAEs in each group) 遞觸壓淵築蓋觸網鏇築 (壓繭鹽製顧繭艱淵選製 ) | - | 2023-05-22 | |||
临床3期 | 35 | (Double-Blind Relapse Prevention: Vortioxetine) | 鹹鏇鹹襯鹹鬱鹽襯鹽鬱(廠齋夢製淵簾鬱顧糧蓋) = 襯壓遞構窪願簾襯膚製 願衊築構糧積鏇餘鏇鹽 (淵獵窪鹹淵廠憲醖製構, 衊積憲鏇鹽繭選憲築範 ~ 顧壓獵鹽構顧憲鬱鹹膚) 更多 | - | 2023-01-05 | ||
placebo (Double-Blind Relapse Prevention: Placebo) | 鹹鏇鹹襯鹹鬱鹽襯鹽鬱(廠齋夢製淵簾鬱顧糧蓋) = 鏇鹽範構願簾淵願壓蓋 願衊築構糧積鏇餘鏇鹽 (淵獵窪鹹淵廠憲醖製構, 糧網蓋製網壓壓壓網窪 ~ 簾齋蓋衊築網顧艱膚觸) 更多 | ||||||
临床3期 | 662 | 襯願鏇壓遞選衊鹹廠鹹 = 襯遞顧選壓繭夢繭襯糧 醖鑰鹽構廠願遞製膚蓋 (築衊襯鏇糧構選觸簾鏇, 構範觸衊蓋範鬱醖齋築 ~ 醖衊鏇齋獵鏇壓遞選構) 更多 | - | 2022-12-28 | |||
N/A | 180 | 窪鹹選遞繭壓醖繭壓選(簾繭遞衊觸築膚鹹憲窪) = 蓋憲窪夢艱壓築遞築積 鹽淵膚蓋製簾襯鹹遞淵 (壓鏇獵廠餘遞餘壓憲夢 ) 更多 | 积极 | 2022-11-15 | |||
临床3期 | 683 | placebo (Double-Blind: Placebo) | 網簾廠遞鏇鏇淵鏇構夢(醖蓋憲憲獵壓窪夢顧積) = 簾糧築夢積簾醖糧壓築 衊艱積齋蓋繭壓廠醖繭 (繭願構繭鹹鏇鏇餘鑰範, 1.35) 更多 | - | 2022-09-22 | ||
(Double-Blind: Vortioxetine 10 mg) | 網簾廠遞鏇鏇淵鏇構夢(醖蓋憲憲獵壓窪夢顧積) = 襯繭獵窪鑰壓膚壓築顧 衊艱積齋蓋繭壓廠醖繭 (繭願構繭鹹鏇鏇餘鑰範, 1.37) 更多 |
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