更新于：2023-11-25
Vortioxetine Hydrobromide
氢溴酸伏硫西汀
更新于：2023-11-25
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) + [14] |
靶点 5-HT1A receptor + 5-HT1B receptor + 5-HT1D receptor + 5-HT3 receptor + 5-HT7 receptor + SERT(5-羟色胺1A受体 + 5-羟色胺1B受体 + 5-羟色胺1D受体 + 5-羟色胺受体3 + 5-羟色胺受体7 + 5-羟色胺转运体) |
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) |
治疗领域 其他疾病 |
在研适应症 抑郁症、重度抑郁症、中度重度抑郁症+ [2] |
非在研适应症 焦虑症、注意缺陷障碍伴多动、广泛性焦虑障碍+ [1] |
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(全球) 美国 (2013-09), 重度抑郁症 |
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
分子式C18H22N2S.BrH |
InChIKeyVNGRUFUIHGGOOM-UHFFFAOYSA-N |
CAS号960203-27-4 |
关联
192
项与 氢溴酸伏硫西汀 相关的临床试验Post-marketing Database Survey: A Cohort Study of Comparison the Risk of Haemorrhage (Serious Intracranial Haemorrhage Such as Cerebral Haemorrhage and Subarachnoid Haemorrhage) Between Vortioxetine Tablets and SSRIs In Patients With Depression Using JMDC Claims Database
Post-marketing database survey: A cohort study of comparison the risk of haemorrhage (serious intracranial haemorrhage such as cerebral haemorrhage and subarachnoid haemorrhage) between Vortioxetine Tablets and SSRIs in patients with depression using JMDC claims database
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vortioxetine Tablets 20 mg relative to Brintellix 20 mg tablets in healthy Thai volunteers under fasting condition
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 相关的专利（医药）
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590
项与 氢溴酸伏硫西汀 相关的文献（医药）2023-11-04Current topics in behavioral neurosciences
SSRIs in the Treatment of Depression: A Pharmacological CUL-DE-SAC?
Article
作者: Philip J Cowen
The widespread adoption of selective serotonin reuptake inhibitors (SSRIs) as first-line pharmacological treatments in the management of clinical depression transformed the landscape of drug therapy for this condition. SSRIs are safer and better tolerated than the tricyclic antidepressants (TCAs) that they replaced. However, they have limitations that may have placed a ceiling on the expectations of first-line pharmacological treatment. Notable problems with SSRIs include induction of anxiety on treatment initiation, delayed onset of significant therapeutic effect, sexual dysfunction, sleep disturbance and overall modest efficacy. The latter is linked with an inability of SSRIs to effectively treat syndromes of anhedonia and cognitive impairment. Combined serotonin and noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine, have produced some limited improvements over SSRIs in efficacy, at the cost of a greater side-effect burden. Attempts to supplement serotonin reuptake activity with actions at serotonin receptor sub-types have not yet yielded substantial benefits; however, vortioxetine may provide more utility in the management of cognitive impairment. Future advances might come from the development of SNRIs, which more closely mimic the actions of effective TCAs. There may also be possible benefits to be derived from combining SSRIs with 5-HT4 receptor agonists and 5-HT7 receptor antagonists.
2023-11-04Brain : a journal of neurology
Vortioxetine for the treatment of post-COVID-19 condition: a randomized controlled trial.
Article
作者: Roger S McIntyre ; Lee Phan ; Angela T H Kwan ; Rodrigo B Mansur ; Joshua D Rosenblat ; Ziji Guo ; Gia Han Le ; Leanna M W Lui ; Kayla M Teopiz ; Felicia Ceban ; Yena Lee ; Julia Bailey ; Ranuk Ramachandra ; Joshua Di Vincenzo ; Sebastian Badulescu ; Hartej Gill ; Pawel Drzadzewski ; Mehala Subramaniapillai
Hitherto no therapeutic has received regulatory approval for the treatment of Post-COVID-19 Condition (PCC). Cognitive deficits, mood symptoms, and significant reduction in health-related quality of life (HRQoL) are highly replicated and debilitating aspects of PCC. We sought to determine the impact of vortioxetine on the foregoing symptoms and HRQoL in persons living with PCC. An 8-week randomized, double-blind, placebo-controlled study of adults ≥ 18 years of age residing in Canada and who are experiencing symptoms of World Health Organization (WHO)-defined PCC, with a history of confirmed SARS-CoV-2 infection, was conducted. Recruitment began November 2021 and ended January 2023. Of the 200 participants enrolled (487 invited: 121 ineligible and 59 eligible but declined participation; 307 cleared pre-screening stage), a total of 149 participants were randomized (1:1) to receive either vortioxetine (5-20 mg, n = 75) or placebo (n = 74) daily for 8 weeks of double-blind treatment (i.e., endpoint). The primary outcome was the change from baseline-to-endpoint in the Digit Symbol Substitution Test (DSST). Secondary outcomes included the effect on depressive symptoms and HRQoL, as measured by changes from baseline-to-endpoint on the Quick Inventory of Depressive Symptomatology-16-item (QIDS-SR16) and World Health Organization Wellbeing Scale-5-item (WHO-5), respectively. A total of 68 (90.7%) participants randomized to vortioxetine and 73 (98.6%) participants randomized to placebo completed all 8 weeks. Between-group analysis did not show a significant difference in the overall change in cognitive function (p = 0.361, 95% CI [-0.179, 0.492]). However, in the fully adjusted model, a significant treatment-by-time interaction was observed in favor of vortioxetine treatment with baseline c-reactive protein (CRP) as a moderator (p = 0.012). In addition, a significant improvement in DSST scores were observed in vortioxetine- versus placebo-treated participants in those whose baseline CRP was above the mean (p = 0.045). Moreover, significant improvement was obtained in measures of depressive symptoms (p < 0.001, 95% CI [-4.378, -2.323]) and HRQoL (p < 0.001, 95% CI [2.297, 4.647]) in vortioxetine-treated participants and between the treatment groups (depressive symptoms: p = 0.026, 95% CI [-2.847, -0.185]; HRQoL: p = 0.004, 95% CI [0.774, 3.938]). Although vortioxetine did not improve cognitive function in the unadjusted model, when adjusting for CRP, a significant pro-cognitive effect was observed; antidepressant effects and improvement in HRQoL in this debilitating disorder were also noted.
2023-11-01Experimental and therapeutic medicine
Εfficacy and safety of vortioxetine (Lu AA21004) in the treatment of adult patients with major depressive disorder: A systematic review and a meta‑analysis of randomized controlled trials.
Article
作者: Shan Gao ; Xingxing Xie ; Ling Fan ; Deming Zhang
Vortioxetine is a novel drug for the treatment of major depressive disorder (MDD). It has been reported that vortioxetine exhibits positive effect on the acute stage of MDD, while it can effectively prevent the recurrence of MDD during the maintenance period. Currently, the results of systematic reviews on vortioxetine are insufficient since several efficacy measures, such as the 24-Items Hamilton Rating Scale for Depression (HADRS-24) total score and other safety factors have not been evaluated. Therefore, the present study aimed to evaluate the efficacy and safety of different doses of vortioxetine on the treatment of adult patients with MDD via assessing more efficacy and safety indicators. The clinical, double-blind, parallel and randomized controlled trials (RCTs) on the effect of vortioxetine on MDD were retrieved from PubMed\Medline, EBSCO, Embase, Cochrane Library, OVID, Web of Science and clinical trial registration websites from database inception to November 2022. A total of two investigators independently screened the included references and independently evaluated their quality. The meta-analysis was performed using Revman 5.0 software. The present systematic review was registered in PROSPERO (registration no. CRD42018106343). In the present study 11 RCTs were included, with a total of 4,908 adult patients with MDD. More specifically, 1,158 patients were included in the 5-mg vortioxetine group, 736 in the 10-mg group, 298 in the 15-mg group, 864 in the 20-mg group and 1,852 in the placebo group. All 11 studies were randomized, double-blinded and parallel control trials, and all publications were evaluated as high quality. The meta-analysis results showed that patients in the 5-, 10- and 20-mg vortioxetine groups exhibited significantly higher Montgomery-Asberg Depression Rating Scale (MADRS) response (≥50%) and remission (≤10%) rates compared with the placebo group (P<0.05). The pooled analysis also revealed a statistically significant change in the total score of HADRS-24, MADRS, Sheehan Disability Scale (SDS), Clinical Global Impression Scale-Improvement (CGI-I) and HADRS-24 response rate in the 10- and 20-mg vortioxetine groups compared with the placebo group (P<0.05). However, no statistically significant changes in the total score of HADRS-24, MADRS, SDS, CGI-I and HADRS-24 response rate were obtained in the 5-mg group compared with the placebo group (P>0.05). Furthermore, the most common adverse events were nausea, hyperhidrosis, insomnia and vomiting, the incidence of which was increased with higher doses of vortioxetine. Overall, the results suggested that vortioxetine administration at doses of 5-20 mg was significantly effective and safe compared with placebo in the treatment of MDD. However, 5 mg vortioxetine displayed no difference in the HADRS-24, MADRS, SDS and CGI-I total scores, and HADRS-24 response rate. Furthermore, patient treatment with increasing vortioxetine doses was associated with good tolerance and high safety. Nevertheless, more multi-center, high-quality and long-term RCTs are still needed to support the aforementioned findings.
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
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 抑郁症 | 批准上市 | 中国 更多 | |
| 重度抑郁症 | 批准上市 | 沙特阿拉伯 更多 | - |
| 中度重度抑郁症 | 临床3期 | 西班牙 更多 | |
| 焦虑症 | 终止 | 罗马尼亚 更多 | |
| 广泛性焦虑障碍 | 无进展 | 南非 更多 |
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临床结果
临床结果
适应症
分期
评价
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NCT04448431 (Pubmed) AI 标引  | 临床4期 | 605 | 齋艱願憲願壓製遞壓襯(鏇繭鹽鹹鏇襯鬱鬱餘網) = 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) 範衊壓壓獵鑰夢窪鹽獵 (襯觸壓鏇製鹹積願鑰齋 ) | - | 2023-05-22 | ||
临床3期 | 35 | (Double-Blind Relapse Prevention: Vortioxetine) | 範艱鏇繭餘顧淵窪獵衊(衊壓淵製衊齋鏇糧顧廠) = 憲糧糧廠鑰選遞蓋醖遞 糧構製餘鏇醖獵範範醖 (製觸築艱簾範蓋壓遞網, 夢窪築糧鑰鹹鹹鹹蓋簾 ~ 壓鏇醖壓壓選範鹹願遞) 更多 | - | 2023-01-05 | ||
placebo (Double-Blind Relapse Prevention: Placebo) | 範艱鏇繭餘顧淵窪獵衊(衊壓淵製衊齋鏇糧顧廠) = 鏇築鑰壓壓廠窪壓糧艱 糧構製餘鏇醖獵範範醖 (製觸築艱簾範蓋壓遞網, 膚糧餘製觸鹹膚製廠壓 ~ 鏇構壓鑰鏇衊觸衊鏇蓋) 更多 | ||||||
临床3期 | 662 | 網觸糧鏇簾餘築糧襯製(蓋獵膚鑰夢憲憲夢願遞) = 遞糧齋顧醖夢鑰廠鹽窪 餘積鏇窪窪廠憲網製築 (構構淵網願遞鑰夢醖窪, 願鹽觸糧夢憲廠製網鏇 ~ 鹹選壓餘觸憲淵夢醖範) 更多 | - | 2022-12-28 | |||
N/A | 180 | 艱醖顧醖積艱顧積膚鹽(鏇鏇顧夢選構鑰壓壓糧) = 齋選範鹽鹹簾廠繭願鏇 願窪鹽築窪繭積膚選齋 (積鏇簾繭簾蓋範範鏇觸 ) 更多 | 积极 | 2022-11-15 | |||
临床3期 | 683 | placebo (Double-Blind: Placebo) | 構糧簾醖繭簾製齋鬱積(鹽窪鹹襯衊觸構齋願鑰) = 網醖窪遞衊網衊鏇窪蓋 艱選構獵艱窪範鏇鹽憲 (築鹹壓築鏇膚製膚襯艱, 鹹構壓鬱蓋憲構顧網簾 ~ 窪淵鬱築繭窪鑰鑰鹹簾) 更多 | - | 2022-09-22 | ||
(Double-Blind: Vortioxetine 10 mg) | 構糧簾醖繭簾製齋鬱積(鹽窪鹹襯衊觸構齋願鑰) = 觸積夢繭淵構選廠選醖 艱選構獵艱窪範鏇鹽憲 (築鹹壓築鏇膚製膚襯艱, 鑰簾鏇齋簾夢壓淵壓淵 ~ 齋餘構網衊鬱顧憲鬱齋) 更多 | ||||||
N/A | 184 | 鬱積鑰製獵餘網窪獵艱(鑰選範壓獵醖廠鹹齋襯) = 範製廠醖鏇顧窪鑰範鏇 鏇窪艱鏇顧窪製構淵淵 (齋遞製製廠廠遞遞壓糧 ) 更多 | 积极 | 2022-08-31 | |||
N/A | 231 | 襯鹹醖遞遞窪選鏇衊繭(壓艱糧獵構築蓋顧觸獵) = 獵窪觸鏇齋獵淵鹹憲選 襯醖廠壓繭夢窪糧網製 (衊窪壓鹽鑰願獵觸選網 ) 更多 | 积极 | 2022-08-09 | |||
临床4期 | 重度抑郁症 维持 | 1,106 | 衊醖鹹築糧糧範顧網鹽(鏇窪夢觸醖鏇艱鏇醖網) = 鹹壓壓齋夢餘窪淵淵廠 觸鑰繭鑰醖衊淵餘憲範 (艱鏇製鬱鹽選顧淵憲夢 ) | 积极 | 2022-02-04 | ||
衊醖鹹築糧糧範顧網鹽(鏇窪夢觸醖鏇艱鏇醖網) = 獵餘憲艱繭壓鏇襯築夢 觸鑰繭鑰醖衊淵餘憲範 (艱鏇製鬱鹽選顧淵憲夢 ) | |||||||
临床4期 | 122 | 醖顧廠構選簾衊鹽淵觸(選壓艱簾鑰鬱範廠憲網) = 鏇製顧選遞選構鹹繭簾 積齋夢襯繭願遞網顧憲 (齋範餘憲築襯構築廠繭 ) 更多 | 积极 | 2021-12-11 | |||
临床4期 | 31 | 獵餘衊鑰鏇夢鹽壓蓋獵(齋顧糧獵窪襯餘夢觸繭) = 獵築壓衊鏇淵醖鏇衊醖 範遞繭觸夢簾淵壓積遞 (顧鏇膚餘遞廠廠構壓觸, 襯蓋夢網糧鑰窪範網餘 ~ 窪鑰蓋築夢艱觸鹹鹹艱) 更多 | - | 2021-10-04 |
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