A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

开始日期2025-01-30

申办/合作机构

University Medical Center of Utrecht

[+1]

ChiCTR2400088162 / Suspended临床4期IIT

Clinical study on the application of remimazolam combined with esketamine in hysteroscopic surgery

开始日期2025-01-01

申办/合作机构

诸暨市人民医院

ChiCTR2400093592 / SuspendedN/AIIT

Effect of intravenous esketamine on lung injury in patients undergoing thoracoscopic surgery under single-lung ventilation - Esketamine lung protection

开始日期2025-01-01

申办/合作机构-

100 项与盐酸艾司氯胺酮相关的临床结果

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100 项与盐酸艾司氯胺酮相关的转化医学

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100 项与盐酸艾司氯胺酮相关的专利（医药）

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2,003

项与盐酸艾司氯胺酮相关的文献（医药）

2025-03-01·JOURNAL OF AFFECTIVE DISORDERS

Effect of continuous esketamine infusion on brain white matter microstructure in patients with major depression: A diffusion tensor imaging study

Article

作者: Liu, Xiang ; Peng, Dechang ; Wan, Xin ; Li, Jiangping ; Deng, Yingke ; Wei, Zhipeng ; Wu, Guojiang ; Liu, Yumeng ; Li, Lifeng ; Li, Haijun

INTRODUCTION:

Esketamine has demonstrated acute antidepressant effects in patients with major depressive disorder (MDD). This study investigated whether these effects associate with reversible white matter fiber integrity recovery using diffusion imaging.

METHOD:

Twenty patients with MDD and 20 healthy controls received 2-week esketamine treatment. Patients received 0.25 mg/kg intravenous esketamine. Emotional and cognitive recovery were assessed. Diffusion tensor imaging and tract-based spatial statistics evaluated white matter fiber integrity pre/post-treatment. Correlation analyses examined associations between white matter changes and clinical scales.

RESULTS:

Compared to controls, patients with MDD exhibited decreased fractional anisotropy (FA) values of cerebral white matter fibers involving the association fibers, the commissural fibers and projection fibers. Esketamine effectively reduced depression, anxiety, and suicidal ideation scores while improving cognitive function. However, no reversible recovery of compromised white matter integrity was observed after 2 weeks of esketamine treatment. FA reductions in projection fibers correlated with anxiety and suicidal ideation severity.

LIMITATIONS:

Concurrent sertraline use and lack of placebo control limited our ability to isolate esketamine's effects. The wide age range may have introduced response variability. We used minimal effective dosages based on previous research. The small sample size limited statistical power. Larger, more controlled studies are needed to validate these preliminary findings.

DISCUSSION:

This study enhances MDD neuropathological understanding, with widespread white matter impairment and associations between projection fibers and symptom severity. While producing significant antidepressant effects, short-term esketamine did not recover compromised white matter microstructure.

2025-02-01·PSYCHIATRY RESEARCH

Safety outcomes of ketamine for treatment-resistant depression in clinical settings and development of the ketamine side effect tool-revised (KSET-R)

Article

作者: Thornton, Nicollette ; Loo, Colleen ; Barreiros, Ana Rita ; Bayes, Adam ; Martin, Donel ; Gálvez-Ortiz, Verònica ; Massaneda-Tuneu, Clara ; Cao, Thanh Vinh ; Dong, Vanessa ; Moreno, Dalia ; Short, Brooke ; Glozier, Nicholas ; Beesley, Laura

BACKGROUND:

Ketamine and its derivates (e.g. esketamine) are increasingly used in clinical settings for treatment-resistant depression (TRD). Ketamine can give rise to acute, cumulative and longer-term side effects (SEs) across a treatment course. The Ketamine Side Effect Tool (KSET) examines adverse effects though its length has affected feasibility for use in clinical settings.

OBJECTIVE:

To estimate the frequency of ketamine SEs occurring in real-world settings using the KSET, additional validated scales and laboratory measures. Utilising this naturalistic data, to develop a shorter, more feasible and validated tool (KSET-Revised; KSET-R).

METHODS:

Retrospective patient and safety data from three outpatient services were collected which included KSET symptom questions, standardised scales and laboratory measures. We calculated frequency of SEs occurring intra-session, intersession and at follow-up. Revision of the KSET included removal of items based on a priori criteria. Construct and concurrent validity were examined by comparison of specific KSET items and the overall tolerability rating with standardised scales.

RESULTS:

Descriptive statistics including SE frequencies are reported and the KSET-R is detailed: a shorter tool with construct and concurrent validity for specific items, along with the overall tolerability rating.

LIMITATIONS:

small sample size for follow-up data; predominantly subcutaneous racemic and intranasal esketamine analysed - other routes and formulations not examined; and subjective not objective cognition measured.

CONCLUSIONS:

Naturalistic data gives an estimate of frequency of ketamine SEs within session, between sessions and at follow-up. The KSET-R has improved feasibility and clinical utility and is recommended for use in clinical practice where ketamine is prescribed.

2025-02-01·PSYCHIATRY RESEARCH

Perioperative administration of esketamine during cesarean section is a double-edged sword

Letter

作者: Nagamine, Takahiko

413

项与盐酸艾司氯胺酮相关的新闻（医药）

2025-01-02

·Endpoints

Neumora's major depression drug flunks first of three Phase 3 trials

Neuroscience drug developer Neumora Therapeutics released highly anticipated results from the first of three Phase 3 trials for its experimental major depression drug, saying Thursday that navacaprant was not statistically significant at improving patients’ depressive symptoms better than placebo in the late-stage KOASTAL-1 trial. Neumora is hoping to compete against Johnson & Johnson, which is also running Phase 3 studies for its experimental MDD drug, called aticaprant, and markets the esketamine spray Spravato. Both companies are developing kappa opioid receptor (KOR) antagonists, which are meant to hit upon the reward processing and dopamine pathways. The biotech’s stock price $NMRA fell 80% in Thursday morning trading in reaction to the news. In the 383-adult KOASTAL-1, navacaprant and placebo both led to a -12.5 change from baseline on the primary endpoint, the Montgomery-Asberg Depression Rating Scale (MADRS). “We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD,” Neumora head of R&D Rob Lenz said in a statement. “There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants.” Neumora CEO Henry Gosebruch said the company will share more details on its pipeline at the JP Morgan Healthcare Conference later this month. The first results for Neumora’s once-daily pill are a preview of more to come. The company is running two additional identical pivotal trials dubbed KOASTAL-2 and KOASTAL-3. Those trials are expected to read out in the first half of this year, the company has said. In their note from December, Stifel analysts said Neumora’s drug likely only needs to succeed in two of the trials. “The other two would likely have sufficient data for an NDA as the psychiatry division typically doesn’t penalize sponsors for a negative study,” the analysts wrote Dec. 16. If navacaprant makes it to market for major depression, the analysts predict almost $3 billion in peak worldwide revenues. The readout also marks a key moment for the KOR space. J&J is expected to release Phase 3 data for aticaprant this year. If either company is successful, it will open up a new treatment option in depression, a large market that has lacked effective new treatments and run into clinical or regulatory disappointments . The opportunity is so large that ARCH Venture Partners named Neumora the “ Really Big Neuroscience Company ” when it formed the startup. The company attracted key industry leaders to its management team, including Gosebruch , the former AbbVie strategy chief. It then went public in a $250 million IPO in September 2023. While Gosebruch was at AbbVie, the drug giant got a label expansion in depression for its drug Vraylar. In prior studies, navacaprant helped patients with moderate-to-severe MDD in a Phase 2 trial, but it didn’t hit statistical significance in the overall study population when factoring in mildly depressed patients. Neumora did not include mildly depressed patients in its Phase 3. BlackThorn Therapeutics, which designed the Phase 2 trial, was acquired by Neumora in 2020. Editor’s note: This story was updated to include stock price reaction.

临床3期临床2期临床结果并购IPO

2024-12-22

·信狐药迅

全球首个～只需每周一次皮下注射～先为达生物GLP-1新药提交上市申请|新受理（12.16-12.22）

本周药品注册受理数据，分门别类呈现，一目了然。(12.16-12.22）新药上市申请药品名称企业注册分类受理号伊诺格鲁肽注射液杭州先为达生物科技股份有限公司1CXSS2400141伊诺格鲁肽注射液杭州先为达生物科技股份有限公司1CXSS2400140 新药临床申请药品名称企业注册分类受理号JX2201胶囊浙江京新药业股份有限公司1CXHL2401428JX2201胶囊浙江京新药业股份有限公司1CXHL2401427JX2201胶囊浙江京新药业股份有限公司1CXHL2401426JX2201胶囊浙江京新药业股份有限公司1CXHL2401425LIT0922胶囊励缔(杭州)医药科技有限公司1CXHL2401420LIT0922胶囊励缔(杭州)医药科技有限公司1CXHL2401419FNX020片成都凡诺西生物医药科技有限公司1CXHL2401418FNX020片成都凡诺西生物医药科技有限公司1CXHL2401417POC101胶囊长春长乘医药科技有限公司1CXHL2401416POC101胶囊长春长乘医药科技有限公司1CXHL2401414GT919胶囊标新生物医药科技(上海)有限公司1CXHL2401411D-2570片益方生物科技(上海)股份有限公司1CXHL2401421GT919胶囊标新生物医药科技(上海)有限公司1CXHL2401412GT919胶囊标新生物医药科技(上海)有限公司1CXHL2401410WJ01024片苏州君境生物医药科技有限公司1CXHL2401407POC101胶囊长春长乘医药科技有限公司1CXHL2401415HC016脂质复合物注射液浙江海昶生物医药技术有限公司1CXHL2401413ABSK131胶囊上海和誉生物医药科技有限公司1CXHL2401406ABSK131胶囊上海和誉生物医药科技有限公司1CXHL2401405HTMC0658片上海壹典医药科技开发有限公司1CXHL2401404HTMC0658片上海壹典医药科技开发有限公司1CXHL2401403TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401402TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401401TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401400注射用QD202上海魁特迪生物科技有限公司1CXHL2401393己二酸他雷替尼胶囊葆元生物医药科技(杭州)有限公司1CXHL2401392JYP0061片广州嘉越医药科技有限公司1CXHL2401387JYP0061片广州嘉越医药科技有限公司1CXHL2401386JYP0061片广州嘉越医药科技有限公司1CXHL2401385BIOT006片厦门宝太生物科技股份有限公司1CXHL2401397BIOT006片厦门宝太生物科技股份有限公司1CXHL2401396HW201877胶囊武汉人福创新药物研发中心有限公司1CXHL2401395HW201877胶囊武汉人福创新药物研发中心有限公司1CXHL2401394注射用LX22001山东罗欣药业集团股份有限公司2.1CXHL2401424注射用LX22001山东罗欣药业集团股份有限公司2.1CXHL2401423注射用BSY001北京北生研医药科技有限公司2.2CXHL2401422BCM235双释干混悬剂上海云晟研新生物科技有限公司2.2CXHL2401409BCM235双释干混悬剂上海云晟研新生物科技有限公司2.2CXHL2401408注射用BJ007上海宝济药业股份有限公司2.2CXHL2401399HY2233口服溶液浙江恒研医药科技有限公司2.2CXHL2401391吸入用H057上海汇伦医药股份有限公司2.2;2.4CXHL2401390盐酸艾司氯胺酮注射液宜昌人福药业有限责任公司2.4CXHL2401398恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2401389恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2401388注射用T320山西纳安生物科技股份有限公司1CXSL2400888PT886凡恩世制药(北京)有限公司1CXSL2400889OVV-01 注射液上海荣瑞医药科技有限公司1CXSL2400886同种异体脂肪间充质基质细胞注射液天士力医药集团股份有限公司1CXSL2400882OVV-01 注射液上海荣瑞医药科技有限公司1CXSL2400887IBI3007信达生物制药(苏州)有限公司1CXSL2400884注射用BR111浙江博锐生物制药有限公司1CXSL2400885FT-003注射液方拓生物科技(苏州)有限公司1CXSL2400883注射用PCNAT-01安达生物药物开发(深圳)有限公司1CXSL2400878MWN105注射液上海民为生物技术有限公司1CXSL2400879注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400871注射用BGB-C354广州百济神州生物制药有限公司1CXSL2400877重组人源化抗表皮生长因子受体单抗注射液上海津曼特生物科技有限公司1CXSL2400876LP-003 注射液天辰生物医药(苏州)有限公司1CXSL2400875SYS6002石药集团巨石生物制药有限公司1CXSL2400873贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400870阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400872SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2400869 仿制药申请药品名称企业注册分类受理号复合磷酸氢钾注射液内蒙古白医制药股份有限公司3CYHS2404445维生素B6注射液江西远超医药科技有限公司3CYHS2404453碘[131I]化钠口服溶液广东君奇医药科技有限公司3CYHS2404438重酒石酸去甲肾上腺素注射液山西普恒制药有限公司3CYHS2404450尼莫地平口服溶液江苏联环药业股份有限公司3CYHS2404433尼莫地平口服溶液江苏联环药业股份有限公司3CYHS2404430盐酸溴己新口服溶液河北汇德旭盛医药科技有限公司3CYHS2404429盐酸溴己新口服溶液河北汇德旭盛医药科技有限公司3CYHS2404428双氯芬酸依泊胺贴杭州端本医药科技有限公司3CYHS2404427注射用乳糖酸红霉素广东态森德制药有限公司3CYHS2404422盐酸赛庚啶口服溶液苏州华健瑞达医药技术有限公司3CYHS2404421重酒石酸去甲肾上腺素注射液浙江尚科生物医药有限公司3CYHS2404416硫酸镁注射液江苏润恒制药有限公司3CYHS2404413硫酸镁注射液江苏润恒制药有限公司3CYHS2404412倍他米松磷酸钠注射液河南利华制药有限公司3CYHS2404411头孢克肟颗粒广东华南药业集团有限公司3CYHS2404410布美他尼注射液云南华派医药科技有限公司3CYHS2404407环索奈德吸入气雾剂上海上药信谊药厂有限公司3CYHS2404405苯磺贝他斯汀口腔崩解片漯河市汇创医药有限公司3CYHS2404404吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司3CYHS2404418吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司3CYHS2404417盐酸丙卡特罗颗粒四川大冢制药有限公司3CYHS2404400熊去氧胆酸片中山百灵生物技术股份有限公司3CYHS2404398苯磺酸氨氯地平口服溶液四川奥邦古得药业有限公司3CYHS2404396盐酸伐地那非口腔崩解片哈尔滨三联药业股份有限公司3CYHS2404392聚乙二醇4000散郑州泰丰制药有限公司3CYHS2404390盐酸布比卡因注射液湖北津药药业股份有限公司3CYHS2404387马来酸曲美布汀片浙江诺得药业有限公司3CYHS2404381复方电解质醋酸钠注射液浙江高跖医药科技股份有限公司3CYHS2404375恩格列净二甲双胍缓释片山东力诺制药有限公司3CYHS2404373恩格列净二甲双胍缓释片山东力诺制药有限公司3CYHS2404372硫代硫酸钠注射液赤峰源生药业有限公司3CYHS2404371肾上腺素注射液武汉久安药物研究院有限公司3CYHS2404369盐酸溴己新口服溶液湖北民康药业集团有限公司3CYHS2404368盐酸溴己新口服溶液湖北民康药业集团有限公司3CYHS2404367氨酚羟考酮片北京华素制药股份有限公司3CYHS2404364醋酸特利加压素注射液武汉华龙生物制药有限公司3CYHS2404363阿仑膦酸钠口服溶液湖北欣泽霏药业有限公司3CYHS2404385吸入用盐酸丙卡特罗溶液石家庄四药有限公司3CYHS2404384枸橼酸西地那非片广东培杰药物研究有限公司4CYHS2404446阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404444阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404443恩他卡朋双多巴片(II)浙江京新药业股份有限公司4CYHS2404442阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404441盐酸伐昔洛韦片浙江车头制药股份有限公司4CYHS2404440注射用硫酸艾沙康唑湖南科伦制药有限公司4CYHS2404461玻璃酸钠滴眼液江苏福邦药业有限公司4CYHS2404460他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404459他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404458他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404457比索洛尔氨氯地平片江苏德源药业股份有限公司4CYHS2404456甲磺酸沙非胺片南京正大天晴制药有限公司4CYHS2404455甲磺酸沙非胺片南京正大天晴制药有限公司4CYHS2404454丁溴东莨菪碱注射液广东博卓医药科技有限公司4CYHS2404439依折麦布阿托伐他汀钙片(II)重庆圣华曦药业股份有限公司4CYHS2404452双氯芬酸钠肠溶片四川天德制药有限公司4CYHS2404451甲磺酸沙非胺片石家庄四药有限公司4CYHS2404435枸橼酸氢钾钠颗粒成都恒瑞制药有限公司4CYHS2404449枸橼酸西地那非片广东培杰药物研究有限公司4CYHS2404448枸橼酸西地那非片广东培杰药物研究有限公司4CYHS2404447注射用磷酸特地唑胺吉林津升制药有限公司4CYHS2404420甲磺酸沙非胺片石家庄四药有限公司4CYHS2404436盐酸尼卡地平注射液江西东抚制药有限公司4CYHS2404434甲磺酸沙非胺片四川科伦药业股份有限公司4CYHS2404432甲磺酸沙非胺片四川科伦药业股份有限公司4CYHS2404431美阿沙坦钾片合肥立方制药股份有限公司4CYHS2404426美阿沙坦钾片合肥立方制药股份有限公司4CYHS2404425盐酸氮斯汀滴眼液江西马应龙美康药业有限公司4CYHS2404424注射用氟氧头孢钠四川制药制剂有限公司4CYHS2404423卡泊三醇搽剂福元药业有限公司4CYHS2404415钆特醇注射液河北仁合益康药业有限公司4CYHS2404414富马酸伏诺拉生片重庆世森医药科技有限公司4CYHS2404409富马酸伏诺拉生片重庆世森医药科技有限公司4CYHS2404408非奈利酮片天地恒一制药股份有限公司4CYHS2404406比索洛尔氨氯地平片浙江百代医药科技有限公司4CYHS2404419盐酸奥洛他定滴眼液武汉新瑞医药科技有限公司4CYHS2404399硫酸羟氯喹片珠海润都制药股份有限公司4CYHS2404397培哚普利氨氯地平片(III)浙江华海药业股份有限公司4CYHS2404395格拉司琼透皮贴片杭州朱养心药业有限公司4CYHS2404393阿昔莫司胶囊河北锐健医药科技有限公司4CYHS2404391小儿法罗培南钠颗粒广东九明制药有限公司4CYHS2404389异氟烷福建海西联合药业有限公司4CYHS2404388夫西地酸乳膏西藏奥斯必秀医药有限公司4CYHS2404386阿贝西利片齐鲁制药有限公司4CYHS2404403阿贝西利片齐鲁制药有限公司4CYHS2404402阿贝西利片齐鲁制药有限公司4CYHS2404401盐酸尼卡地平注射液浙江花园药业有限公司4CYHS2404394氧(气态)河南心连心深冷能源股份有限公司4CYHS2404361氧(液态)河南心连心深冷能源股份有限公司4CYHS2404360妥布霉素滴眼液江苏宝东医药科技有限公司4CYHS2404383氧氟沙星滴耳液江苏宝东医药科技有限公司4CYHS2404382阿托伐他汀钙片浙江江北药业有限公司4CYHS2404380阿托伐他汀钙片浙江江北药业有限公司4CYHS2404379氢溴酸替格列汀片常州千红生化制药股份有限公司4CYHS2404378盐酸头孢卡品酯颗粒苏州盛达药业有限公司4CYHS2404377依折麦布阿托伐他汀钙片(II)浙江昂利康制药股份有限公司4CYHS2404376替米沙坦氨氯地平片江苏百佑药业有限公司4CYHS2404374夫西地酸乳膏广东科泓药业有限公司4CYHS2404370托吡酯片山东新时代药业有限公司4CYHS2404366托吡酯片山东新时代药业有限公司4CYHS2404365达格列净二甲双胍缓释片(I)南通联亚药业股份有限公司4CYHS2404362盐酸他喷他多口服溶液江苏恩华药业股份有限公司3CYHL2400265注射用甲磺酸萘莫司他湖南复瑞生物医药技术有限责任公司3CYHL2400262注射用甲磺酸萘莫司他湖南复瑞生物医药技术有限责任公司3CYHL2400261注射用甲磺酸萘莫司他山东化药医药科技有限公司3CYHL2400260洛索洛芬钠凝胶贴膏乐明药业(苏州)有限公司4CYHL2400266克霉唑阴道片浙江百代医药科技有限公司4CYHL2400264氟比洛芬凝胶贴膏乐明药业(苏州)有限公司4CYHL2400263水痘减毒活疫苗浙江天元生物药业有限公司3.3CXSL2400874Catumaxomab注射液(卡妥索单抗注射液)广州凌腾生物医药有限公司3.2CXSL2400880Catumaxomab注射液(卡妥索单抗注射液)广州凌腾生物医药有限公司3.2CXSL2400881 进口申请药品名称企业注册分类受理号氟替美维吸入粉雾剂GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND5.1JXHS2400116氟替美维吸入粉雾剂GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND5.1JXHS2400115盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2400114盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2400113伊曲莫德片EVEREST MEDICINES (SINGAPORE) PTE. LTD.5.1JXHS2400112布西珠单抗注射液Novartis Pharma Schweiz AG2.2JXSS2400112布西珠单抗注射液Novartis Pharma Schweiz AG2.2JXSS2400111氯法齐明软胶囊Dong-A ST Co., Ltd.5.2JYHS2400065PF-07220060Pfizer Inc.1JXHL2400299PF-07220060Pfizer Inc.1JXHL2400298PF-07220060Pfizer Inc.1JXHL2400297KFA115Novartis Pharma AG1JXHL2400295KFA115Novartis Pharma AG1JXHL2400294KFA115Novartis Pharma AG1JXHL2400293KFA115Novartis Pharma AG1JXHL2400292硫酸瑞美吉泮口崩片Pfizer Inc.2.4JXHL2400296AZD8630AstraZeneca AB1JXSL2400245AZD8630AstraZeneca AB1JXSL2400244AZD8630AstraZeneca AB1JXSL2400243DS-3939aDaiichi Sankyo, Inc.1JXSL2400242AZD4360AstraZeneca AB1JXSL2400241SAR402663注射液Sanofi-Aventis Recherche & Developpement1JXSL2400240Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1;2.2JXSL2400238Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1;2.2JXSL2400239 中药相关申请药品名称企业注册分类受理号仁术健胃颗粒南京中山制药有限公司1.1CXZS2400037小儿苓龙早熟颗粒盈科瑞(天津)创新医药研究有限公司1.1CXZL2400094散热止咳颗粒新奇康药业股份有限公司1.1CXZL2400091白头翁皂苷B4江西中医药大学1.2CXZL2400093白头翁皂苷B4栓江西中医药大学1.2CXZL2400092 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

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2024-12-18

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RECOVER Clinical Study Shows Meaningful Benefits of LivaNova’s VNS Therapy System in Select Secondary Endpoints for Unipolar Patients with Treatment-Resistant Depression

LONDON--( BUSINESS WIRE )--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced that the journal Brain Stimulation has published two pivotal articles chronicling the unipolar cohort data set for the RECOVER clinical study . The researchers evaluated the safety and efficacy of LivaNova’s VNS Therapy™ System and its effectiveness on quality of life and daily function in this population of patients with treatment-resistant unipolar depression. Overall, the articles concluded that active VNS Therapy, as compared with a no-stimulation control (or sham VNS Therapy), safely and effectively demonstrated clinically meaningful therapeutic effects on depressive symptoms and positive effects on quality of life and daily function. These findings support the use of VNS Therapy to deliver vagus nerve stimulation (VNS) in treatment-resistant depression (TRD) patients. A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. At baseline, unipolar patients in the study failed more than 13 antidepressant treatments (on average) – this included, for the majority, one or more interventional therapies (e.g., transcranial magnetic stimulation, electroconvulsive therapy, or esketamine). While the RECOVER study did not meet the primary endpoint due to a strong and unforeseen response in the sham group, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline. Further, the RECOVER study demonstrated statistically significant and clinically meaningful benefits in select secondary endpoints for this cohort. Based upon these findings and the positive effects for those who received VNS Therapy, the Company conducted additional in-depth data analyses and plans to submit three additional critical manuscripts to report on the outcomes. “ Participants in the trial had severe, refractory depression that could not be treated effectively with other FDA-approved treatments, and most have had large portions of their lives profoundly negatively impacted by depression,” said Charles Conway, MD, director of the Washington University Resistant Mood Disorders Center at Washington University School of Medicine in St. Louis. Conway is the study's lead investigator and first author of the mood outcomes article. “ For this sample of markedly ill TRD participants, I am encouraged by the findings, which revealed that active VNS performed better than sham VNS treatment in all measures, and that active VNS demonstrated clinically meaningful, safe therapeutic effects. Multiple clinician, patient, and independent observer ratings separated between the active and sham unipolar arms.” The first article , “ Vagus Nerve Stimulation in Treatment-Resistant Depression: A One-Year, Randomized, Sham-Controlled Trial,” 1 outlines the safety and effectiveness of adjunctive VNS Therapy in treating patients with unipolar TRD. The primary endpoint measured the difference in the percentage of time in antidepressant response between active VNS Therapy and sham VNS Therapy, with response defined as at least a 50% reduction from baseline using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. While the predetermined p-value was p<0.023, the observed mean percentage of time in response was p=0.137. Analyses of secondary endpoints revealed antidepressant benefits significantly favoring active VNS Therapy as opposed to sham VNS Therapy as measured by ratings from on-site clinicians (Clinical Global Impression-Improvement, or CGI-I), patients themselves (Quick Inventory of Depressive Symptomology–Self Report, or QIDS-SR), and offsite masked raters (Quick Inventory of Depressive Symptomology–Clinical, or QIDS-C). Results included: Participants with active VNS Therapy had significantly more percentage of time in response with CGI-I ( P =0.004) and QIDS-SR ( P =0.049) compared with sham VNS Therapy. For percentage of time in partial response, active VNS Therapy showed significant benefit with QIDS-C ( P =0.006) and CGI-I ( P <0.001) compared with sham VNS Therapy. Partial response is defined as improvement of ≥30% from baseline for QIDS-C or a score of ≤3 for CGI-I. No differences between treatment groups were observed in suicidal ideation and intent as measured by the S-STS 2 items 6 and 8 ( P =0.239). “ The composite of the mood findings, especially in the partial response rates on multiple ratings scales, along with the low rate of adverse events, support that this device demonstrated safe antidepressant efficacy for these patients,” said Conway. The second article , “ Effects of Vagus Nerve Stimulation on Daily Function and Quality of Life in Markedly Treatment-Resistant Major Depression: Findings from a One-Year, Randomized, Sham-Controlled Trial,” 3 assesses VNS Therapy’s ability to improve quality of life (QoL) and daily function in patients with unipolar TRD. The results of this analysis demonstrated that adjunctive VNS Therapy provided greater improvements in QoL and daily function in patients with unipolar TRD when compared with sham VNS Therapy. Results included: The active VNS Therapy group showed greater improvements over the sham control group as measured by the mean change in scores from baseline in the Mini-Q-LES-Q 4 ( P =0.050) and WPAI 5 item 6 (health condition’s effect on regular activities; P =0.050) used as continuous variables. Time spent in a state of clinically meaningful benefit was significantly greater with active VNS Therapy compared to sham VNS Therapy, using the Q-LES-Q 6 ( P =0.029), Mini-Q-LES-Q ( P =0.011) and WPAI item 6 ( P =0.039). No differences between treatment groups were observed in the mean change in score from baseline with the WHODAS 7 2.0 ( P =0.304) and the EQ-5D 8 visual analog scale ( P =0.125). “ Adjunctive VNS Therapy improves quality of life and psychosocial function in patients with major depression who have not benefited from multiple antidepressant treatments,” said A. John Rush, MD, Professor Emeritus at Duke-National University of Singapore Medical School and lead author on this article. “ For these patients who are profoundly impaired, largely unemployed, and markedly treatment-resistant, depressive symptoms alone are an incomplete gauge of the clinical impact of treatments. Symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness.” These two articles published in Brain Stimulation are the first in a series that will detail the RECOVER unipolar cohort data. Three subsequent, supportive manuscripts will feature outcomes from in-depth data analyses on select secondary endpoints. The totality of data presented in these five complementary articles will serve as the basis for LivaNova’s formal request to the U.S. Centers for Medicare and Medicaid Services (CMS) for VNS Therapy coverage. “ Patients in the RECOVER study are some of the most critically ill among those with treatment-resistant depression and they need more treatment options when existing therapies fail,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “ The data from the RECOVER study and predecessor studies has shown that VNS Therapy is a safe and effective treatment option for these patients, providing hope for patients and families in similar situations who have few viable options. We look forward to sharing more of the important outcomes from the unipolar cohort with the intent to offer VNS Therapy as an important adjunctive treatment for these patients.” RECOVER launched in 2019 as part of a Coverage with Evidence Development framework per the CMS National Coverage Determination process. For the unipolar cohort of RECOVER, enrollment was completed in March 2023, and the 12-month follow-up for those patients was completed in March 2024. No new safety issues were identified in the study. About RECOVER LivaNova’s VNS Therapy™ System has been approved for the treatment of depression since earning CE Mark in 2001 and 510(k) from the U.S. Food and Drug Administration in 2005. RECOVER stands for A P r ospective, Multi-c e nter, Randomized C ontrolled Blinded Trial Dem o nstrating the Safety and Effectiveness of V NS Therapy System as Adjunctiv e Therapy Versus a No Stimulation Control in Subjects With Treatment- R esistant Depression. The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. About VNS Therapy for Depression The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug Administration-approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments The most commonly reported side effects are voice alteration or hoarseness, prickling or tingling in the skin, increased coughing, shortness of breath, and sore throat. Infection is the most common complication of the surgical procedure. Important safety information is available at www.livanova.com/depression/en-us/safety-information . References Conway CR, et al. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/j.brs.2024.12.1191. The Sheehan Suicidality Tracking Scale (S-STS) is a clinician-administered rating scale that tracks treatment-emergent suicidal ideation and behaviors. Rush AJ, et al. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/j.brs.2024.12.1187. Mini-Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form) is a quality-of-life measure from a self-report assessing the patient’s degree of enjoyment and satisfaction across seven domains as a subset of the Q-LES-Q. WPAI item 6 is a function measure from the Work Productivity and Activity Impairment (WPAI) Questionnaire. Q-LES-Q is a quality-of-life measure from a self-report assessing the patient’s degree of enjoyment and satisfaction experienced over the previous seven days across 14 domains. WHODAS (World Health Organization Disability Assessment Schedule) assesses the patient’s ability to perform activities in the previous month in six domains. The EuroQoL Five-Dimension Questionnaire (EQ-5D) is a generic QoL measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com . Safe Harbor Statement This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the RECOVER study and the VNS Therapy™ System, Symmetry™. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

临床结果临床研究

100 项与盐酸艾司氯胺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10627	盐酸艾司氯胺酮	N01AX14 N06AX27	DB11823

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
抑郁症	中国	Janssen-Cilag International NV	2023-04-17
中度重度抑郁症	澳大利亚	Janssen-Cilag Pty Ltd.	2021-03-09
重度抑郁症	欧盟	Janssen-Cilag International NV	2019-12-18
重度抑郁症	冰岛	Janssen-Cilag International NV	2019-12-18
重度抑郁症	列支敦士登	Janssen-Cilag International NV	2019-12-18
重度抑郁症	挪威	Janssen-Cilag International NV	2019-12-18
麻醉	中国	江苏恒瑞医药股份有限公司	2019-11-18
难治性抑郁症	美国	Janssen Pharmaceuticals, Inc.	2019-03-05
疼痛	德国	Pfizer Inc.	1997-08-01

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适应症	最高研发状态	国家/地区	公司	日期
自杀意念	临床3期	美国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	保加利亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	爱沙尼亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	德国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	匈牙利	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	马来西亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	斯洛伐克	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	南非	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	韩国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	西班牙	Janssen Research & Development LLC	2017-06-09

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02497287 \| NCT03373253 (ICEBERG, Pubmed \| Front Psychiatry)	临床3期	功能障碍	696	Esketamine nasal spray + SSRI/SNRI	鏇鬱選鏇廠壓構糧簾顧(網簾簾構構醖繭獵窪獵) = 齋餘築淵範鑰廠艱廠壓鹹廠鑰簾簾齋鏇網壓觸 (觸網鹹築網遞艱築選鏇, 21.8 ~ 29.4)	积极	2024-10-07
				esketamine nasal spray (Real-world treatment (RWT))	鏇鬱選鏇廠壓構糧簾顧(網簾簾構構醖繭獵窪獵) = 壓壓鹽膚願選遞獵鏇簾鹹廠鑰簾簾齋鏇網壓觸 (觸網鹹築網遞艱築選鏇, 6.9 ~ 16.1)
ChiCTR2200061956 (not available, Pubmed \| BMC Anesthesiol)	临床4期	髋部骨折 brain-derived neurotrophic factor (BDNF) \| 5-hydroxytryptamine (5-HT)	90	Esketamine	憲糧範製壓艱憲夢積選(願憲觸鬱構範糧遞窪鏇) = 積鹽壓醖願鏇醖壓積廠鑰顧觸艱顧艱範艱繭獵 (醖遞衊憲獵願糧餘鹹餘 ) 更多	积极	2024-09-28
				Saline	憲糧範製壓艱憲夢積選(願憲觸鬱構範糧遞窪鏇) = 淵範觸鏇膚鏇鹽獵蓋淵鑰顧觸艱顧艱範艱繭獵 (醖遞衊憲獵願糧餘鹹餘 ) 更多
NCT04757675 (Pubmed \| Transl Pediatr)	早期临床1期	斜视	-	Intranasal esketamine 2 mg/kg	餘鹽夢襯製積選鏇築繭(築鹽衊醖廠鹹夢糧鹽鏇) = More gastrointestinal events were observed in Group K (P<0.001) 鹽衊鹽顧鏇簾艱醖淵餘 (餘蓋夢淵獵艱製鑰餘壓 )	不佳	2024-08-01
				Intranasal esketamine 1 mg/kg and dexmedetomidine 1 µg/kg
ChiCTR2100054199 (Pubmed \| JAMA Netw Open)	早期临床1期	产后抑郁症	298	Esketamine	窪築網築鑰繭蓋鬱獵醖(憲廠憲蓋襯顧齋積顧獵) = 觸簾淵簾襯蓋範淵製鑰範膚膚淵範遞餘醖鑰淵 (淵窪襯鹹簾積襯簾糧築 )	积极	2024-03-06
				Control (Saline)	窪築網築鑰繭蓋鬱獵醖(憲廠憲蓋襯顧齋積顧獵) = 膚壓壓網積壓壓製遞構範膚膚淵範遞餘醖鑰淵 (淵窪襯鹹簾積襯簾糧築 )
ChiCTR2200060387 (Pubmed \| BMC Pharmacol Toxicol)	临床4期	产后抑郁症 stress \| inflammation	120	Esketamine 0.2 mg/kg	餘壓襯夢鬱鏇顧網膚鹹(醖願鬱齋遞鑰膚蓋夢鹹) = 製醖齋廠築積鏇鑰範積遞壓鑰鹹觸範網齋顧積 (廠壓鏇繭鬱築夢憲簾鹽 )	积极	2023-11-23
				Placebo	餘壓襯夢鬱鏇顧網膚鹹(醖願鬱齋遞鑰膚蓋夢鹹) = 網繭糧網齋鬱繭積窪觸遞壓鑰鹹觸範網齋顧積 (廠壓鏇繭鬱築夢憲簾鹽 )
ChiCTR2000041187 (Pubmed \| Laryngoscope)	临床2期	-	-	Esketamine 0.5 mg kg−1	製鬱淵鬱構齋繭鑰構遞(簾膚壓範鏇遞膚築齋願) = 夢網鹽齋繭艱獵鹽製襯餘蓋鏇糧鬱蓋顧繭壓範 (艱範鹹顧衊淵簾鬱鬱選 ) 更多	积极	2023-11-01
				Sufentanil 0.125 μg kg−1	製鬱淵鬱構齋繭鑰構遞(簾膚壓範鏇遞膚築齋願) = 鏇壓繭淵廠鹽艱醖觸襯餘蓋鏇糧鬱蓋顧繭壓範 (艱範鹹顧衊淵簾鬱鬱選 ) 更多
NCT04338321 (ESCAPE-TRD, PipelineReview) 人工标引	临床3期	重度抑郁症	676	Esketamine	齋遞壓膚範選壓構糧鹽(觸製鏇廠選蓋鹽蓋鏇鏇) = 餘鏇顧鏇鑰膚夢鏇網糧憲廠糧範鹽積廠艱壓網 (壓廠範選鏇鹹壓選選觸 ) 更多	积极	2023-10-09
				Quetiapine	齋遞壓膚範選壓構糧鹽(觸製鏇廠選蓋鹽蓋鏇鏇) = 蓋壓遞網蓋襯齋窪壓鹽憲廠糧範鹽積廠艱壓網 (壓廠範選鏇鹹壓選選觸 ) 更多
NCT04338321 (ESCAPE-TRD, Pubmed \| N Engl J Med)	临床3期	难治性抑郁症	-	Esketamine nasal spray	鬱遞簾範夢齋繭鏇顧鹹(積糧積築製鑰鬱齋鏇鹽) = 範願糧廠艱夢繭繭鹽憲鬱製構餘網願淵範醖築 (遞壓積鬱淵遞壓襯鹽夢 ) 更多	积极	2023-10-05
				Extended-release quetiapine	鬱遞簾範夢齋繭鏇顧鹹(積糧積築製鑰鬱齋鏇鹽) = 夢鑰膚顧範製餘築願蓋鬱製構餘網願淵範醖築 (遞壓積鬱淵遞壓襯鹽夢 ) 更多
NCT03097133 \| NCT03039192 (ASPIRE I and II, Pubmed)	临床3期	自杀意念 \| 重度抑郁症	451	Esketamine nasal spray + standard of care	艱積願膚繭憲窪蓋夢憲(範遞憲夢蓋範夢獵鏇憲) = 淵鏇淵壓築製壓製顧積廠廠網構願鹽鑰糧廠鏇 (廠鹹艱艱廠鑰襯蓋鹽廠 ) 更多	积极	2023-08-11
				Placebo + standard of care	艱積願膚繭憲窪蓋夢憲(範遞憲夢蓋範夢獵鏇憲) = 壓衊範糧艱醖艱築鏇衊廠廠網構願鹽鑰糧廠鏇 (廠鹹艱艱廠鑰襯蓋鹽廠 ) 更多