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FDA Green Lights New Study Testing IV Ketamine Infusion For Depressive Disorder
FDA Green Lights New Study Testing IV Ketamine Infusion For Depressive Disorder
After a full review of healthcare provider Ehave Inc.'s (OTC:EHVVF) IND application, the U.S. Food and Drug Administration (FDA) has authorized the company to proceed with a clinical trial assessing low-dose, weekly intravenous (IV) ketamine infusion in participants with Major Depressive Disorder (MDD).
The FDA seems to be granting more permits for clinical studies with ketamine. It recently approved the same drug for the prevention of injury in organ transplants.
As defined, this open-label trial will involve 35 participants with an inadequate response to at least two FDA-approved antidepressant therapies, including the current course of antidepressant therapy, at a sufficient dose and duration for the current episode.
See Also: Psychedelics Company Filament Signs Licensing Deal
Ehave CEO Ben Kaplan says the upcoming clinical trial on IV-ketamine infusion in patients MDD represents a key milestone for the company's clinical programs.
"Intravenously administered ketamine may offer the potential for the remission of the symptoms in patients with MDD; however, it has not yet been approved by FDA for this purpose. This study will use an electroencephalography machine to measure the brain's activity and response while the intravenous ketamine is being delivered," Kaplan stated.
Ehave board member Dr. Ali added that studying the effects of IV ketamine by observing changes in brain activity on EEG is an approach that can "help advance the identification of potential biomarkers, which could one day be used to identify the specific patients who will respond best to ketamine intervention upfront, allowing the recommendation to made sooner in the course of illness and decreasing the amount of trial and error with treatment options."
Forms Of Administration And Treatment Indications
Facing the fact that currently FDA-approved depression treatments such as selective serotonin reuptake inhibitors (SSRIs,) serotonin-norepinephrine reuptake inhibitors (SNRIs,) monoamine oxidase inhibitors (MAOIs,) tricyclic antidepressants (TCAs) and psychotherapy often do not help severe cases, the dissociative anesthetic ketamine has been repurposed as an off-label analgesic and antidepressant.
Research on ketamine's rapid antidepressant effects have been a breakthrough specifically for disorders such as MDD.
Clinical research and real-world feasibility have shown disadvantages of this administration route for ketamine, including patient discomfort, greater risk of diversion to the illicit market, and potentially serious adverse reactions.
On the other hand, IV use of racemic ketamine is the more traditional way of administration as it has long been used as an anesthetic at much higher doses.
Ehave sustains that IV administration of ketamine includes benefits such as greater dose control and reduced cost of drug acquisition, as the many outpatient clinics offering IV-ketamine therapy for MDD across the US seem to show.
Photo courtesy of True Touch Lifestyle and Gorodenkoff on Shutterstock and Doc James on Wikimedia Commons.
After a full review of healthcare provider Ehave Inc.'s (OTC:EHVVF) IND application, the U.S. Food and Drug Administration (FDA) has authorized the company to proceed with a clinical trial assessing low-dose, weekly intravenous (IV) ketamine infusion in participants with Major Depressive Disorder (MDD).
在对医疗保健提供者进行全面审查后EHave Inc.'s(OTC:EHVVF)IND申请,美国食品和药物管理局(FDA)已授权该公司进行一项临床试验,评估每周静脉注射低剂量氯胺酮对患有严重抑郁障碍(MDD)的参与者的疗效。
The FDA seems to be granting more permits for clinical studies with ketamine. It recently approved the same drug for the prevention of injury in organ transplants.
FDA似乎对氯胺酮的临床研究给予了更多的许可。它是最近的批准了同样的药物用于预防器官移植中的损伤。
As defined, this open-label trial will involve 35 participants with an inadequate response to at least two FDA-approved antidepressant therapies, including the current course of antidepressant therapy, at a sufficient dose and duration for the current episode.
根据定义,这项开放标签试验将涉及35名参与者,他们至少对FDA批准的两种抗抑郁药物治疗反应不足,包括当前疗程的抗抑郁药物治疗,剂量和持续时间对当前事件都足够。
See Also: Psychedelics Company Filament Signs Licensing Deal
另见:迷幻药公司灯丝签署许可协议
Ehave CEO Ben Kaplan says the upcoming clinical trial on IV-ketamine infusion in patients MDD represents a key milestone for the company's clinical programs.
EHave首席执行官本·卡普兰他说,即将进行的静脉输注氯胺酮治疗MDD患者的临床试验是该公司临床项目的一个关键里程碑。
"Intravenously administered ketamine may offer the potential for the remission of the symptoms in patients with MDD; however, it has not yet been approved by FDA for this purpose. This study will use an electroencephalography machine to measure the brain's activity and response while the intravenous ketamine is being delivered," Kaplan stated.
“静脉注射氯胺酮可能会缓解MDD患者的症状;然而,它还没有被FDA批准用于这一目的。这项研究将使用脑电图仪来测量静脉注射氯胺酮时大脑的活动和反应,”卡普兰说。
Ehave board member Dr. Ali added that studying the effects of IV ketamine by observing changes in brain activity on EEG is an approach that can "help advance the identification of potential biomarkers, which could one day be used to identify the specific patients who will respond best to ketamine intervention upfront, allowing the recommendation to made sooner in the course of illness and decreasing the amount of trial and error with treatment options."
埃哈德董事会成员Ali博士他补充说,通过观察脑电活动的变化来研究静脉注射氯胺酮的影响,是一种c一个“帮助推进潜在生物标志物的识别,有一天可能被用来预先识别对氯胺酮干预反应最好的特定患者,允许在病程中更早地提出建议,并减少治疗方案的试验和错误的数量。”
Forms Of Administration And Treatment Indications
给药形式和治疗适应症
Facing the fact that currently FDA-approved depression treatments such as selective serotonin reuptake inhibitors (SSRIs,) serotonin-norepinephrine reuptake inhibitors (SNRIs,) monoamine oxidase inhibitors (MAOIs,) tricyclic antidepressants (TCAs) and psychotherapy often do not help severe cases, the dissociative anesthetic ketamine has been repurposed as an off-label analgesic and antidepressant.
面对目前FDA批准的抑郁症治疗方法,如选择性5-羟色胺再摄取抑制剂(SSRIs)、5-羟色胺去甲肾上腺素再摄取抑制剂(SNRI)、单胺氧化酶抑制剂(MAOIs)、三环类抗抑郁药(TCA)和心理疗法往往对重症患者无效,游离麻醉剂氯胺酮已被重新用作标签外的止痛剂和抗抑郁剂。
Research on ketamine's rapid antidepressant effects have been a breakthrough specifically for disorders such as MDD.
对氯胺酮快速抗抑郁作用的研究已经取得了突破性进展,特别是针对MDD等疾病。
Clinical research and real-world feasibility have shown disadvantages of this administration route for ketamine, including patient discomfort, greater risk of diversion to the illicit market, and potentially serious adverse reactions.
临床研究和现实世界的可行性表明,这种氯胺酮给药途径的缺点包括患者不适、更大的转移到非法市场的风险,以及潜在的严重不良反应。
On the other hand, IV use of racemic ketamine is the more traditional way of administration as it has long been used as an anesthetic at much higher doses.
另一方面,静脉注射外消旋氯胺酮是更传统的给药方式,因为它长期以来一直被用作麻醉剂,剂量要高得多。
Ehave sustains that IV administration of ketamine includes benefits such as greater dose control and reduced cost of drug acquisition, as the many outpatient clinics offering IV-ketamine therapy for MDD across the US seem to show.
EHave坚持认为,静脉注射氯胺酮包括更好的剂量控制和降低药物获取成本等好处,正如美国各地许多为MDD提供静脉注射氯胺酮疗法的门诊诊所似乎所表明的那样。
Photo courtesy of True Touch Lifestyle and Gorodenkoff on Shutterstock and Doc James on Wikimedia Commons.
照片由True Touch Lifestyle和Gorodenkoff在Shutterstock上以及Doc James在Wikimedia Commons上提供。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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