Trifecta Research Study: Examining Hormone Replacement Therapy, Magnetic e-Resonance Therapy, Ibogaine, and 5-MeO-DMT in the Treatment of Posttraumatic Stress Disorder and Traumatic Brain Injury-related Cognitive Symptoms

The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.

开始日期2025-09-01

申办/合作机构

The Johns Hopkins University

NCT06812221

/ Completed临床1/2期

A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Trial of Multiple Sublingual 5-MeO-DMT Microdoses for Reducing Anxiety and/or Depression in Patients With Mild Cognitive Impairment.

This Phase I/II clinical trial aims to test the effectiveness of a new sublingual formulation of 5-MeO-DMT in reducing symptoms of anxiety, depression, and cognitive decline in individuals with mild to moderate Alzheimer's disease. The study will include participants who have a Clinical Dementia Rating (CDR) score between 0.5 and 1, indicating mild to moderate cognitive impairment, and who meet specific educational and cognitive criteria. Participants must have an ACE-III score of ≤86 for individuals with a high level of education (≥12 years) or <62 for those with a low educational level (≤12 years). Additionally, participants must show moderate to high levels of anxiety, as indicated by the State-Trait Anxiety Inventory (STAI), with STAI-S (State) scores ≥20 for men and ≥23 for women, and STAI-T (Trait) scores ≥20 for men and ≥26 for women. Participants also need to exhibit moderate to severe depressive symptoms, as indicated by a Beck Depression Inventory (BDI) score of ≥21.
To ensure that participants are cognitively functional but showing signs of impairment, they are assessed with the CDR and ADLQ scales to confirm they can maintain independence in daily activities. All participants must have scores above the threshold on cognitive screening tests like the ACE III and IFS, ensuring no significant cognitive impairment at the baseline.
The study will measure the effects of 5-MeO-DMT through a range of cognitive and psychiatric assessments:
Cognitive Assessments: These include the Rey Auditory Verbal Learning Test (RAVLT) for episodic memory, the Trail Making Test (TMT) for attention and cognitive flexibility, the Semantic and Phonological Fluency Test (SFT-FAS) for verbal fluency, the Paced Auditory Serial Addition Test (PASAT) for processing speed, and the Digit Span Subtests (DSS) for attention and working memory. These tests will provide valuable insights into how 5-MeO-DMT affects cognitive functions.
Psychiatric Assessments: These will assess symptoms of suicidal ideation (SSI), mood (BDI II), anxiety (STAI), and mindfulness (FFMQ), as well as self-reported cognitive complaints (CQC). These evaluations will help determine the psychological and emotional impact of 5-MeO-DMT on participants.
In addition, the study will include biochemical assessments such as microalbuminuria, blood glucose levels, liver and kidney function, cholesterol, and several biomarkers of inflammation. Cardiovascular evaluations will also be conducted during the trial, ensuring comprehensive monitoring of potential side effects.
This structured approach will help researchers assess the cognitive and psychological effects of 5-MeO-DMT in individuals with mild to moderate Alzheimer's disease. By focusing on participants with elevated anxiety, depression, and early cognitive decline, this trial aims to provide insights into the therapeutic potential of 5-MeO-DMT for neurodegenerative conditions.

开始日期2024-12-15

申办/合作机构

Biomind Labs, Inc.

[+1]

NCT06511947

/ Recruiting临床1期

An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.

开始日期2024-08-01

申办/合作机构

GH Research Plc

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100 项与蟾蜍素相关的专利（医药）

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847

项与蟾蜍素相关的文献（医药）

2025-10-01·NEUROPSYCHOPHARMACOLOGY

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study

Article

作者: Ortiz, Javier E ; Bruno, Diana ; Kassuha, Diego E ; Vita, Luciana ; Garcés, M Agustina ; Orosco, Lorena ; Bruno, Martin A ; Zanino, Mariana ; Bistue Millón, Maria Beatriz ; Diez, Pablo ; Feresin, Gabriela E ; Díaz-Dellavalle, Paola ; Albarracín, Sergio G ; Noguera, Laura

This Phase I clinical trial is the first to rigorously evaluate the safety, tolerability, and pharmacokinetics of a novel sublingual formulation of 5-MeO-DMT, administered at sub-psychedelic doses to adults with moderate to high levels of anxiety and/or depression, without formal psychiatric diagnosis or ongoing treatment. Using a double-blind, placebo-controlled design, participants received a single weekly sublingual dose of 5-MeO-DMT (6 mg, 9 mg, or 12 mg) or placebo over four weeks. The compound was well tolerated across all groups, with no significant adverse events or signs of organ toxicity; mild side effects such as nausea and headache were transient and self-resolving. Pharmacokinetic analyses showed rapid absorption, with peak plasma concentrations occurring within a median of 20 min and no evidence of drug accumulation. Neurophysiological assessments revealed dose-dependent modulation of brain activity without eliciting full psychedelic effects, supporting the feasibility of repeated sub-psychedelic dosing. Participants remained cognitively and behaviorally stable, maintaining their usual daily activities and social interactions. This study marks a pivotal advancement in the clinical exploration of psychedelic compounds, highlighting the potential of 5-MeO-DMT as a safe, fast-acting compound with favorable tolerability and emerging as a promising candidate for future therapeutic applications. These findings provide critical groundwork for future trials targeting psychiatric populations, positioning 5-MeO-DMT as a novel, fast-acting therapeutic strategy with broad clinical relevance. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06816667.

2025-08-25·Sheng wu gong cheng xue bao = Chinese journal of biotechnology

[Establishment and application of a high-throughput screening method for drugs targeting the 5-hydroxytryptamine 2A receptor based on cellular calcium flux signals].

Article

作者: Chen, Yuanqing ; Zhang, Ruihua ; Li, Liqin ; Shi, Jingjing ; Wang, Miao ; Zhang, Bingqian ; Zhang, Yi

The 5-hydroxytryptamine 2A receptor (5-HT_2AR) is one of the key targets in the development of novel antidepressants. To develop new antidepressants targeting the 5-HT_2A receptor, this study established a high-throughput screening method for drugs targeting the 5-HT_2A receptor based on the principle of detecting calcium flux signals. The immunofluorescence assay and western blotting were employed to evaluate receptor expression levels in the 5-HT_2AR-CHO cell line. The reaction system parameters, including cell seeding density, DMSO concentration, and dye incubation time, were optimized with Z'-factor and signal window values as evaluation indicators. The specificity, precision, stability, and applicability of the method were assessed. Results indicated that the 5-HT_2AR-CHO cell line stably expressed high levels of the 5-HT_2A receptor. The optimized screening method involved a reaction system with 10 000 cells/well, 0.2% DMSO, and 2 h incubation with Calcium 6 dye. The method demonstrated excellent specificity, with inter-batch precision below 10% for the detection of 5-hydroxytryptamine (5-HT) at low, medium, and high concentrations. Testing four compounds that target the 5-HT_2A receptor- agonists 2,5-dimethoxy-4-iodoamphetamine (DOI), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), and lysergic acid diethylamide (LSD), along with the antagonist MDL100907-yielded Z'-factors (at EC₈₀) greater than 0.85 and signal window values over 0.91. The EC₅₀ values of these compounds were in the nanomolar range, and their potency rank order aligned with previously reported data, confirming the reliability of the established method. When being applied to the detection of 38 known active compounds, the method efficiently identified 5-HT_2A receptor agonists and antagonists while showing no response to non-target compounds. In conclusion, this study successfully constructs a high-throughput screening approach for 5-HT_2A receptor-targeting drugs based on calcium flux signals. The method possesses strong specificity, high sensitivity, and robust stability, being suitable for screening antidepressants targeting the 5-HT_2A receptor.

2025-08-01·BIOLOGICAL PSYCHIATRY

Current Evidence for the Role of Rapid-Acting Antidepressants in Bipolar Depression: A Perspective and Plan for Action

Review

作者: Kobayashi, Nene F ; Reif, Andreas ; Bayas, Maximilian ; Möser, Chiara ; Repple, Jonathan

After decades of limited progress in depression treatment, recent advancements have sparked renewed interest in developing novel antidepressants, particularly rapid-acting antidepressants (RAADs). Despite these promising developments, there remains a significant gap in research on bipolar depression. While several antipsychotics have been investigated for their efficacy in bipolar depression due to the reduced risk of mania induction, research on RAADs, such as (es)ketamine, remains scarce despite their demonstrated safety and effectiveness. In this review, we give an overview of current developments in RAADs in the context of bipolar disorder. Both published studies as well as phase II, III, and IV studies on bipolar depression (based on ClinicalTrials.gov) are reviewed in this work. The following RAAD substance classes have been or are currently being investigated as possible treatments for bipolar depression: NMDA antagonists and indirect AMPA agonists (ketamine, esketamine, riluzole, felbamate), GABA_A (gamma-aminobutyric acid A) activators or positive allosteric modulators (zuranolone, pregnenolone, PEA), psychedelics (psilocybin, 5-MeO-DMT), muscarine receptor antagonists (scopolamine), and kappa opioid receptor antagonists (navacaprant). Other than the well-established efficacy and safety of (es)ketamine in treating bipolar depression, there has been little research effort in the treatment of bipolar depression. Recent research into RAADs demonstrates the growing field of novel mechanisms of action in the pharmacological treatment of bipolar depression. However, there is an urgent need for well-controlled clinical studies on RAADs in bipolar depression to expand treatment options and improve outcomes for millions of affected individuals worldwide.

142

项与蟾蜍素相关的新闻（医药）

2025-11-22

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追问daily | 亲密接触能加速伤口愈合；幼儿睡前使用平板未必影响睡眠；在精神疾病诊断上AI超越传统方法

█ 脑科学动态Nature：告别定制化疗法？PERT技术实现一种药物治疗多种基因突变Cell：基于结构设计的Gq偏向性药物显著改善AD小鼠记忆活跃于社交媒体的青少年更容易被网络欺凌吗？幼儿睡前使用平板电脑未必影响睡眠不仅是孤独：社会脆弱性使老年痴呆风险激增50%港大团队利用AI脑模型揭示真实情境下的恐惧调节机制迷幻药的“任性”困局：难以适应传统制药商业模式亲密接触在催产素辅助下加速伤口愈合█ AI行业动态2025年两院院士名单揭晓谷歌发布Nano Banana Pro：深度结合Gemini 3DeepSeek新工具利用线性规划加速MoE模型训练Paradromics脑机接口获批临床试验，致力于让失语者“开口说话”█ AI驱动科学Nature：读心设备已能预测潜意识思维：我们该担忧吗？Alba在精神疾病诊断准确性上超越传统评分量表机器学习助力X射线成像：实时重建生物分子“电影”大型推理模型和人类的思考成本相似AI建议能提高急救决策准确率，但医生接受度存疑VoxeLite：首款达到“人类分辨率”的指尖触觉装置3.5分钟个性化调校：AI驱动的假肢如何重塑行走体验专家警告AI“阿谀奉承”或加剧精神妄想风险：LLM安全引发新担忧精神病理学的经验结构在大型语言模型中得到体现神经系统中的“波动-响应”定律：自发神经活动如何决定学习速度脉冲神经网络模拟大脑机制，将AI对抗攻击防御能力提升两倍HEFMI-ICH：用于脑出血患者脑机接口的混合脑电图-近红外光谱运动想象数据集脑科学动态Nature：告别定制化疗法？PERT技术实现一种药物治疗多种基因突变面对全球数亿受遗传病困扰的患者，如何打破“一种突变一种药”的研发瓶颈？Broad研究所、的 Sarah E. Pierce, Steven Erwood 以及 David R. Liu 等研究人员开发了一种通用的基因编辑策略，旨在通过单一疗法治疗由无义突变引起的多种遗传疾病。该团队通过将先导编辑技术与经过优化的抑制性tRNA相结合，成功在细胞和小鼠模型中实现了对致病性提前终止密码子的通读，恢复了功能性蛋白质的合成。研究团队首先筛选了人类基因组中所有418个tRNA的数万种变体，鉴定出活性最强的抑制性tRNA（suppressor tRNA），并开发了名为PERT的策略。利用先导编辑（Prime Editing），他们将细胞内一个冗余的内源性tRNA基因永久转化为这种优化的抑制性tRNA。在巴顿病、泰-萨克斯病和囊性纤维化的人类细胞模型中，该方法恢复了20-70%的正常酶活性。更重要的是，在赫勒综合征（Hurler syndrome）小鼠模型中，单次治疗恢复了约6%的IDUA酶活性，几乎完全逆转了疾病病理。值得注意的是，该技术表现出高度的安全性，未检测到对天然终止密码子的误读。这项研究为数千种由无义突变（nonsense mutation）引起的遗传病提供了一种通用的治疗新范式。研究发表在 Nature 上。#疾病与健康 #神经机制与脑功能解析 #肥胖治疗 #初级纤毛 #G蛋白偶联受体阅读更多：Pierce, Sarah E., et al. “Prime Editing-Installed Suppressor tRNAs for Disease-Agnostic Genome Editing.” Nature, Nov. 2025, pp. 1–12. www.nature.com, https:///10.1038/s41586-025-09732-2Cell：基于结构设计的Gq偏向性药物显著改善AD小鼠记忆阿尔茨海默病（AD）的治疗长期面临挑战，尤其是如何精准调控大脑中的神经递质信号以恢复记忆功能。胆囊收缩素（CCK）及其受体（CCKBR）在记忆形成中至关重要，但其复杂的下游信号机制限制了药物开发。来自北京大学、山东大学和香港城市大学的 Jin-Peng Sun、Ju-Fang He、Yong Zhang 等研究人员组成的团队，深入解析了CCKBR的信号转导机制，并成功开发出针对特定信号通路的创新药物分子，为AD治疗提供了新策略。研究团队首先利用冷冻电镜（Cryo-EM）技术，解析了CCKBR与不同G蛋白亚型复合物的结构，发现不同的受体构象决定了信号通路的偏向性，并确认Gq信号通路对AD治疗具有积极作用。基于此，团队理性设计了一种能穿透血脑屏障的Gq偏向性激动剂——3r1。在5×FAD阿尔茨海默病小鼠模型（5×FAD mice）中，3r1显著改善了小鼠的空间学习和记忆能力，减少了大脑中β-淀粉样蛋白（amyloid-β plaques）的沉积。进一步的机制研究表明，3r1通过激活CCKBR-Gq通路，上调钙信号分子PLCB4和α分泌酶（ADAM10，一种参与淀粉样前体蛋白非淀粉样途径裂解的酶）的表达，从而促进长时程增强（LTP，神经元突触强度持久增强的现象），最终发挥神经保护作用。该研究不仅揭示了CCKBR-Gq-PLCB4-ADAM10这一全新信号轴，也证明了基于结构的偏向性激动剂设计在神经退行性疾病治疗中的巨大潜力。研究发表在 Cell 上。#疾病与健康 #神经机制与脑功能解析 #记忆机制 #阿尔茨海默病阅读更多：Wang, Jia-Le, et al. “Elucidating Pathway-Selective Biased CCKBR Agonism for Alzheimer’s Disease Treatment.” Cell, vol. 0, no. 0, Nov. 2025. www.cell.com, https:///10.1016/j.cell.2025.10.034活跃于社交媒体的青少年更容易被网络欺凌吗？活跃于社交媒体的青少年往往更容易成为网络欺凌的受害者，但这是否意味着多玩手机就是“罪魁祸首”？为了厘清这一复杂关系，挪威科技大学心理学系的 Habib Niyaraq Nobakht 博士后与其同事 Lars Wichstrøm 和 Silje Steinsbekk 教授组成的研究团队，通过一项长达6年的纵向研究发现，虽然重度社交媒体用户总体上更易受欺凌，但个体增加使用量并不直接导致未来欺凌风险的上升。该研究分析了781名12至18岁挪威青少年的数据，每两年进行一次访谈，重点区分了“自我导向型使用”（如发自拍）和“他人导向型使用”（如点赞评论）。研究采用了个体内部分析，以区分群体差异和个体变化。结果显示，尽管平均发帖量高的“发帖狂”确实比同龄人遭受更多欺凌（组间关联），但当同一个体增加自己的发帖或互动频率时，并不会导致两年后遭受网络欺凌的风险增加。这表明以往研究可能高估了社交媒体使用在欺凌受害中的因果作用。研究者指出，仅劝导青少年减少使用社交媒体收效甚微，预防重点应转向平台内容审核及学校层面的结构性干预。研究发表在 Journal of Youth and Adolescence 上。#疾病与健康 #心理健康与精神疾病 #青少年 #社交媒体 #网络欺凌阅读更多：Nobakht, Habib Niyaraq, et al. “Longitudinal Relations Between Social Media Use and Cyberbullying Victimization Across Adolescence: Within-Person Effects in a Birth Cohort.” Journal of Youth and Adolescence, June 2025. Springer Link, https:///10.1007/s10964-025-02205-9幼儿睡前使用平板电脑未必影响睡眠普遍观点认为电子屏幕的蓝光会干扰睡眠激素，但这一假设在幼儿群体中缺乏家庭环境下的实证。为此，来自波鸿鲁尔大学的发展心理学家 Sabine Seehagen、Neele Hermesch 和 Carolin Konrad 组成的研究团队，打破了以往实验室研究的局限，设计了一项针对家庭环境的综合实验，旨在探究幼儿睡前使用平板电脑对睡眠生理指标的真实影响。研究团队招募了32个家庭，受试幼儿年龄在15至24个月之间。实验核心在于对比两种睡前活动：在平板电脑上观看故事视频与阅读同内容的图画书。为了精准捕捉生理数据，研究人员让幼儿佩戴活动监测手表，并每晚采集三次唾液样本以分析褪黑素的浓度变化。结果显示，虽然褪黑素水平在晚间均有所上升，但两组之间并无差异，这表明平板电脑的蓝光并未如预期般抑制褪黑素分泌。此外，幼儿在入睡时间和睡眠质量上也未表现出显著区别。研究人员指出，虽然单次实验未发现负面影响，但视频内容的兴奋度及环境中的其他光源可能在长期生活中扮演更重要的角色。#疾病与健康 #神经机制与脑功能解析 #儿童发展 #睡眠科学 #实证研究阅读更多：https://news./english/2025-11-20-developmental-psychology-using-tablet-bed-not-nearly-harmful-believed不仅是孤独：社会脆弱性使老年痴呆风险激增50%社会孤立已成为晚年痴呆症的主要风险因素之一，但针对“社会脆弱性”的早期识别和筛查手段尚待完善。来自澳大利亚新南威尔士大学健康大脑老化中心的 Annabel P. Matison 和 Suraj Samtani 等研究人员组成团队，通过长达12年的纵向研究，证实了社会脆弱性与痴呆症发病率之间的显著关联，并开发了相应的筛查指标。研究团队分析了“悉尼记忆与衰老研究”中851名70岁以上社区老年人的数据。这些参与者在基线时均未患痴呆症，研究人员利用五种不同的指数评估了他们的社会脆弱性（social frailty），即个体失去维持社会联系所需资源的状态。在长达12年的随访期间，通过双年度神经心理学测试监测痴呆症的发病情况。结果显示，被判定为社交脆弱的老年人，其患痴呆症的风险比非脆弱人群高出约50%。利用Cox回归（Cox regression）模型分析发现，即使剔除了身体和心理脆弱等干扰因素，社会脆弱性仍是独立的预测因子（风险比 HR 为 1.47）。具体而言，经济满意度低、家庭互动少以及缺乏社会参与是关键的风险指标。这项研究为全科医生提供了基于实证的筛查工具，有助于及早识别高危人群并进行干预。研究发表在 The Journals of Gerontology: Series B 上。#疾病与健康 #个性化医疗 #神经调控 #靶向治疗 #生物材料阅读更多：Matison, Annabel P, et al. “How Well Do Social Frailty Indices Predict Incident Dementia in Older Adults?” The Journals of Gerontology: Series B, vol. 80, no. 10, Oct. 2025, p. gbaf148. Silverchair, https:///10.1093/geronb/gbaf148利用AI脑模型揭示真实情境下的恐惧调节机制传统的实验室恐惧研究往往依赖静态图像，难以还原真实生活中动态变化的恐惧体验，这限制了对社交焦虑等疾病的理解与治疗。香港大学的本Benjamin Becker和 Kun Fu 等研究人员组成团队，挑战了传统假设，旨在通过更贴近现实的方法解析社交恐惧的神经机制及干预手段。▷ Credit: The University of Hong Kong研究团队开展了一项包含67名健康男性的随机双盲安慰剂对照试验。参与者在观看含有强烈恐惧诱发场景的电影（模拟真实生活情境）时接受功能磁共振成像（fMRI）扫描。为了精准捕捉动态情境下的恐惧反应，研究人员引入了一种先进的、受人工智能启发的大脑模型。结果显示，鼻内吸入催产素能显著降低社交情境下的主观恐惧感，但在非社交情境下无效，表现出高度的社会特异性。在神经机制上，催产素增强了左侧中扣带回皮层（lMCC）的激活及其与杏仁核的功能连接，即增强了大脑自上而下的情绪调节能力。此外，催产素还调节了背侧注意网络（DAN）与默认模式网络（DMN）等大尺度脑网络之间的通讯，并被AI模型证实减弱了全脑范围的恐惧表达。这一发现为治疗社交恐惧症和孤独症提供了新的靶向思路。研究发表在 Advanced Science 上。#AI驱动科学 #心理健康与精神疾病 #神经机制与脑功能解析 #神经调控 #社交焦虑阅读更多：Fu, Kun, et al. “Oxytocin Reduces Subjective Fear in Naturalistic Social Contexts via Enhancing Top-Down Middle Cingulate Amygdala Regulation and Brain-Wide Fear Representations.” Advanced Science, vol. 12, no. 38, 2025, p. e03251. Wiley Online Library, https:///10.1002/advs.202503251迷幻药的“任性”困局：难以适应传统制药商业模式随着投资者对精神健康领域兴趣的重燃，迷幻药产业再次受到关注，但伦敦大学圣乔治城市学院的 Sandy Brian Hager 博士指出，该行业面临着根本性的盈利障碍。这项跨学科研究旨在揭示迷幻药特性与现代药物研发经济学之间的错配。Hager 博士利用“资本即权力”的理论框架，分析了2016年至2021年间五大迷幻药公司的财务数据。研究发现，迷幻药表现出一种作为金融资产的“不可控性”（unruliness），这主要源于两大障碍：首先是薄弱的知识产权（IP）保护，因为许多迷幻物质（如裸盖菇素）天然存在或已有长期使用历史，难以申请专利；其次是迷幻体验本身的不可预测性，这使得在实验室环境中进行标准化的医学试验和商业化扩展变得极具挑战。为了克服这些障碍，制药公司正试图通过开发作用时间极短的化合物（如5-MeO-DMT）或完全消除致幻效果的“神经可塑性药物”（neuroplastogens）来改造迷幻药。然而，研究警告称，为了迎合制药商业模式而“驯服”迷幻药，可能会使其失去原本的治疗愿景，最终沦为普通的精神类药物。研究发表在 Finance and Society 上。#心理健康与精神疾病 #跨学科整合 #药物研发 #迷幻药 #金融社会学阅读更多：Hager, Sandy Brian. “The Shifting Fortunes of Corporate Psychedelia.” Finance and Society, Sept. 2025, pp. 1–23. Cambridge University Press, https:///10.1017/fas.2025.10014性生活与亲密接触在催产素辅助下加速伤口愈合社会关系质量与身体健康密切相关，尤其是伴侣间的亲密互动被认为能改善免疫功能。来自苏黎世大学医院和苏黎世大学的 Ekaterina Schneider 与 Cristóbal Hernández 等研究人员，通过一项针对情侣的临床试验，考察了催产素与亲密行为对伤口愈合及压力激素的共同影响，揭示了行为与激素的协同作用。研究团队招募了80对健康情侣，在前臂制造轻微的吸疱伤口（suction-blister wounds，一种通过真空和加热分离皮肤真皮与表皮层的标准化伤口模型），随后进行为期一周的双盲实验。参与者每日使用鼻内催产素或安慰剂，并被分配进行结构化的伴侣互动或自由互动。同时，研究利用生态瞬时评估（ecological momentary assessment，一种在自然生活情境中实时记录行为和感受的方法）追踪日常亲密接触和性行为，并监测唾液皮质醇水平。结果显示，单独使用催产素并不能促进愈合，但当催产素与频繁的日常亲密接触或性行为相结合时，伤口愈合速度显著加快。此外，无论药物分组如何，较高的性活动频率都与较低的皮质醇水平相关。研究者提出，催产素起到了“社会放大器”的作用，增强了亲密互动对生理恢复的积极影响。研究发表在 JAMA Psychiatry 上。#疾病与健康 #心理健康与精神疾病 #催产素 #伤口愈合 #亲密关系阅读更多：Schneider, Ekaterina, et al. “Intranasal Oxytocin and Physical Intimacy for Dermatological Wound Healing and Neuroendocrine Stress: A Randomized Clinical Trial.” JAMA Psychiatry, Nov. 2025. Silverchair, https:///10.1001/jamapsychiatry.2025.3705AI 行业动态2025年两院院士名单揭晓：宁德时代、比亚迪专家入选，破除“四唯”成亮点中国科学院和中国工程院于11月21日正式公布了2025年院士增选结果，共选出144位新当选院士。其中，中国科学院增选院士73人，分布在数学物理、化学、生命科学等多个学部；新当选的研究人员呈现出显著的年轻化趋势，平均年龄为57.2岁，最小年龄仅44岁，60岁以下占比超过67%。中国工程院增选院士71人，涵盖机械与运载、信息与电子、能源与矿业等关键领域。此次增选后，中国科学院院士总数达到908位，两院院士队伍的年龄结构和学科分布得到了进一步优化，体现了对知识和人才的高度尊重。值得关注的是，本次增选在来源分布上极具亮点。除了一批在国防和国家安全领域承担重大科研任务的专家外，来自宁德时代、比亚迪等民营科技领军企业的优秀研究人员也成功当选，标志着企业创新力量的崛起。此外，名单中还包括6位扎根西部边远地区的专家以及13位女性研究人员。据官方介绍，本次评选坚持以重大贡献和学术水平为准绳，重点关注长期奋战在一线的科研人员，并向国家急需的关键领域、新兴学科及交叉学科倾斜。评选过程坚决破除“四唯”（指在人才评价中唯论文、唯职称、唯学历、唯奖项的不良倾向），打破论资排辈的传统，不简单以“帽子”评判人才，旨在更精准地凝聚优秀人才服务国家重大战略。#两院院士 #2025增选 #科研人才 #民营企业 #破除四唯阅读更多：https://www.cas.cn/tz/202511/t20251121_5089455.shtml谷歌发布Nano Banana Pro：深度结合Gemini 3，重新定义AI生图标准谷歌近日正式推出其迄今为止最强大、最全面的图像生成模型 Nano Banana Pro（官方名称 Gemini 3 Pro Image）。该模型深度融合了 Gemini 3 的强大推理能力与世界知识，旨在为用户提供“工作室级别”的设计体验。Nano Banana Pro 显著提升了基础生成能力，支持 2K 和 4K 高分辨率图像输出，并解决了此前版本在长宽比控制上的痛点。其核心亮点在于惊人的视觉一致性与精细控制力：研究人员指出，该模型能同时处理多达 14 张参考图像，并保持 5 个人物的特征统一，极大地拓展了时尚设计与连续叙事创作的边界。此外，用户现可掌握“分子级”的编辑权，自由调整光照、焦点、摄像机角度乃至画面局部，结合 Veo 3 模型更是打通了从图像到视频创作的全流程。在文本渲染与知识整合方面，Nano Banana Pro 解决了 AI 生图长期存在的“乱码”难题。它能生成清晰、准确的多语言文本，甚至支持将图片中的文字翻译并无缝替换原有排版。借助 Gemini 3 的知识库和 Google Search的实时检索能力，该模型能生成具备事实准确性的信息图表、生物示意图，甚至自动化生成演示文稿。为确保内容透明度与安全性，谷歌引入了 SynthID（Digital Watermarking Technology，谷歌开发的将不可察觉信号嵌入AI内容的数字水印技术）和 C2PA 元数据。用户现可在 Gemini 应用中直接验证图像是否由 AI 生成。目前，Nano Banana Pro 正通过 Gemini API、Vertex AI等渠道陆续向全球开发者、企业及订阅用户开放，不同层级的用户将获得差异化的免费或付费额度。#NanoBananaPro #Gemini3 #AI图像生成 #谷歌AI #SynthID阅读更多：https://blog.google/technology/ai/nano-banana-pro/DeepSeek新工具利用线性规划加速MoE模型训练DeepSeek 近日悄然在 GitHub 上开源了一个名为 LPLB 的新代码库，全称为基于线性规划的负载均衡器（Linear-Programming-Based Load Balancer）。该项目旨在解决混合专家模型训练过程中常见的负载不均问题。在 MoE 架构中，某些“专家”可能比其他专家接收到更多的令牌，导致部分 GPU 过载而其他空闲，形成算力浪费。LPLB 利用线性规划（Linear Programming，一种在特定约束条件下寻求最优解的数学方法）算法，通过动态重排序、构建专家副本以及求解最优分配三个步骤，实现并行工作负载的动态均衡。X 平台上的技术分析人士指出，该方案在抽象层级上类似于 NVIDIA 调度流式多处理器（Streaming Multiprocessor，GPU内部的核心计算单元）的方式，表明 DeepSeek 正致力于突破下一代模型的训练效率瓶颈。 LPLB 可以被视为对此前专家并行负载均衡器（EPLB）的扩展与增强。EPLB 主要处理长期存在的静态负载不均，而 LPLB 则专注于解决训练过程中因数据随机性引起的动态负载波动。研究人员通过引入冗余专家副本和边容量概念，利用内置求解器在极短时间内计算出最优的令牌分配方案。为了降低通信开销，该系统采用了 NVSHMEM（NVIDIA OpenSHMEM，一种用于GPU间高效通信的内存共享技术）来替代传统的通信方式。尽管目前 LPLB 仍处于早期研究阶段，且存在忽略非线性计算成本和求解延迟等局限性，但它试图通过数学工具解决大模型训练中的“木桶效应”，即整体速度受限于负载最重的 GPU 这一难题。这为开发者优化大规模 AI 训练架构提供了具有重要参考价值的创新思路。#DeepSeek #LPLB #混合专家模型 #负载均衡 #AI训练优化阅读更多：https://github.com/deepseek-ai/LPLBNeuralink迎来强劲对手：Paradromics脑机接口获批临床试验，致力于让失语者“开口说话”神经技术领域的竞争日益白热化，埃隆·马斯克旗下的 Neuralink 迎来了一位强有力的挑战者。神经技术公司 Paradromics 宣布，其研发的脑机接口已获得美国食品药品监督管理局（FDA）批准，将开展首个长期临床试验。这项试验计划于明年初启动，旨在为两名因严重神经系统疾病而失去语言能力的志愿者植入设备。Paradromics 的首席执行官 Matt Angle 介绍，该技术的核心是一个约 20×20 毫米的铂铱合金电极阵列，它能穿透大脑皮层表面约 1.5 毫米，精准记录单个神经元的活动。这些信号将通过导线传输至植入患者胸部的无线收发器，进而将患者想象说出的语句转化为屏幕文本或合成语音。这是全球首个正式以合成语音生成为核心目标的脑机接口临床试验，标志着该技术在恢复人类沟通能力方面迈出了关键一步。相比于竞争对手，Paradromics 在数据传输速率和设备寿命上表现出独特优势。Matt Angle 指出，基于绵羊的临床前数据显示，该设备的信息传输速率比现有其他设备快约 20 倍，且在植入三年后信号质量未见明显下降，推测其使用寿命可超过十年。相比之下，另一家竞争对手 Synchron 采用的是血管内支架技术，虽然侵入性较低但信号带宽有限；而 Neuralink 则侧重于通过柔性线记录高带宽信号以控制光标或机械臂。来自荷兰乌得勒支大学医学中心的研究人员 Mariska Vansteensel 认为，完全植入式系统是该领域走向临床应用的必由之路。麻省总医院的神经科医生 Leigh Hochberg 也对这一领域的百花齐放表示欢迎，认为这将为未来的患者提供更多样化的技术选择。随着试验的推进，研究人员将重点评估该设备在人体内的安全性、耐用性以及是否能实现长期稳定的语音重构。#Paradromics #脑机接口 #Neuralink #语音恢复 #生物医学工程阅读更多：https:///10.1038/d41586-025-03849-0AI 驱动科学Nature：读心设备已能预测潜意识思维：我们该担忧吗？随着脑机接口技术与人工智能的深度融合，科学家已能从大脑信号中读取潜意识思维，这引发了关于隐私与自主权的广泛担忧。该领域涉及多方专家，包括加州理工学院的 Richard Andersen 团队、纽约脑机接口公司 Synchron 的首席执行官 Tom Oxley、以及慕尼黑工业大学的伦理学家 Marcello Ienca 等。他们共同探讨了神经技术如何从恢复运动功能迈向解析人类深层意图及其带来的伦理挑战。研究指出，脑机接口技术已取得突破性进展。在已故志愿者 Nancy Smith 的临床试验中，植入其后顶叶皮层（posterior parietal cortex，大脑中负责推理、注意力和计划的区域）的设备，能在大脑发出有意识指令前数百毫秒识别出其弹奏意图。与此同时，人工智能显著提升了消费级脑电图的信号处理能力，使其能实时监测专注度等心理状态。然而，伦理学家警告，消费级市场目前处于监管“蛮荒地带”，科技公司可能利用数据推断用户的政治倾向或心理健康。尽管南加州大学的 Maryam Shanechi 等人正致力于构建大脑活动的基础模型（foundation models，通过大规模数据训练的通用AI模型）以治疗精神疾病，但如何确立“神经权利”并防止数据被滥用，已成为亟待解决的全球性议题。文章发表在 Nature 上。#意识与脑机接口 #脑机接口 #AI 驱动科学 #神经伦理 #隐私阅读更多：Drew, Liam. “Mind-Reading Devices Can Now Predict Preconscious Thoughts: Is It Time to Worry?” Nature, vol. 647, no. 8090, Nov. 2025, pp. 575–77. www.nature.com, https:///10.1038/d41586-025-03714-0人工智能助手Alba在精神疾病诊断准确性上超越传统评分量表精神疾病的诊断长期面临专业人员短缺、自评问卷偏差大及临床访谈主观性强等挑战。为了解决这些问题，来自瑞典隆德大学的 Sverker Sikström 教授及其团队开发并验证了一种名为“TalkToAlba”的生成式人工智能临床访谈系统，旨在提供更精准、标准化的诊断辅助。研究结果表明，该AI助手在多项精神疾病的诊断准确性上已超越了医疗领域通用的标准评定量表。该研究纳入了303名参与者，涵盖确诊的抑郁症、焦虑症、强迫症、创伤后应激障碍（PTSD）、多动症（ADHD）、自闭症、饮食障碍、药物滥用和双相情感障碍患者及健康对照组。AI助手 Alba 基于《精神疾病诊断与统计手册第五版》（DSM-5）标准，通过15-20个开放式问题与参与者进行深度访谈，并由另一个系统验证诊断逻辑。结果显示，Alba 在九种常见精神疾病中的八种诊断上，其准确性、灵敏度和特异性均优于传统评定量表。尤为重要的是，Alba 能有效区分症状重叠的疾病（如抑郁与焦虑），而传统量表常在这些区分上表现模糊。此外，参与者反馈显示，AI 助手在互动中表现出了高度的同理心和支持性。研究发表在 Scientific Reports 上。#疾病与健康 #心理健康与精神疾病 #AI驱动科学 #大模型技术 #诊断工具阅读更多：Sikström, Sverker, et al. “Generative AI-Assisted Clinical Interviewing of Mental Health.” Scientific Reports, vol. 15, no. 1, Oct. 2025, p. 37737. www.nature.com, https:///10.1038/s41598-025-13429-x机器学习助力X射线成像：实时重建生物分子“电影”随着X射线自由电子激光器（XFEL）技术的进步，科学家们面临着海量数据处理的瓶颈。为了解决这一难题，来自SLAC国家加速器实验室和斯坦福大学的 Jay Shenoy, Frédéric Poitevin, Gordon Wetzstein 等研究人员开发了一种创新的机器学习算法，旨在实时处理和重建生物分子的三维结构。▷ XFEL SPI 图像采集过程及后续算法在线处理示意图。Credit: Nature Communications (2025).研究团队推出了一种名为X-RAI的方法，全称为基于摊销推理的X射线单粒子成像。传统的重建方法需要对每一张图像独立进行耗时的姿态搜索，而X-RAI利用卷积神经网络作为编码器，直接从二维衍射图像中预测样本的三维方向，并通过基于物理原理的解码器生成三维模型。这种“双向”学习过程使得算法能够随着数据的输入不断优化，且无需将庞大的数据集全部存储在内存中。测试结果显示，X-RAI的处理速度可达每秒160张图像以上，超过了下一代XFEL设施的数据采集速率，并能生成比传统算法更清晰的核糖体和病毒三维图像。这一突破不仅大幅提升了实验效率，还为制作蛋白质与药物相互作用的动态“电影”打开了大门。研究发表在 Nature Communications 上。#AI 驱动科学 #计算模型与人工智能模拟 #X射线成像 #生物分子结构 #实时重建阅读更多：Shenoy, Jay, et al. “Scalable 3D Reconstruction for X-Ray Single Particle Imaging with Online Machine Learning.” Nature Communications, vol. 16, no. 1, July 2025, p. 6812. www.nature.com, https:///10.1038/s41467-025-62226-7大型推理模型和人类的思考成本相似新一代人工智能推理模型在解决复杂问题时表现出与人类惊人的相似性：越难的问题，都需要花越多的时间去“思考”。麻省理工学院麦戈文脑研究所的 Andrea Gregor de Varda 和 Evelina Fedorenko 等研究人员发现，尽管这些模型并非为了模仿人脑而设计，但它们在处理信息时的“思考成本”与人类高度一致。这种趋同性表明，为了稳健地解决复杂任务，人工智能可能正在独立演化出类似人类的逐步处理策略。为了系统地比较人类与人工智能的思维过程，研究团队让大型推理模型和人类志愿者分别解决七种不同类型的推理任务，包括数值算术和一种被称为 ARC 挑战（ARC challenge）的抽象推理测试。对于人类，研究人员精确记录了解决每个问题所需的反应时间；对于模型，则统计了其内部生成的推理词元，即模型在输出最终答案前用于构建思维链的中间步骤数量。结果显示，两者之间存在显著的相关性：那些让人类耗时最长的难题，同样迫使模型生成了最多的推理词元。例如，简单的算术题对双方都较为轻松，而需要推断网格变换规则的 ARC 挑战则让双方都付出了最高的认知成本。这表明，模型生成的思维链长度有效地预测了人类的认知负荷，揭示了机器智能在无预设符号机制的情况下，捕捉到了人类认知中任务复杂性的核心特征。研究发表在 PNAS 上。#认知科学 #计算模型与人工智能模拟 #AI驱动科学 #大模型技术 #思维链阅读更多：de Varda, Andrea Gregor, et al. “The Cost of Thinking Is Similar between Large Reasoning Models and Humans.” Proceedings of the National Academy of Sciences, vol. 122, no. 47, Nov. 2025, p. e2520077122. pnas.org (Atypon), https:///10.1073/pnas.2520077122AI建议能提高急救决策准确率，但医生接受度存疑在生死攸关的急救现场，人工智能能否成为医生的得力助手？Drexel University 的 Angela Mastrianni 和 Aleksandra Sarcevic 等研究人员联合 Children's National Hospital 的临床团队，针对这一问题进行了深入探索。他们通过开发和评估专用的AI系统，发现虽然AI建议能客观提升决策质量，但在实际应用中仍面临医生信任度和自主权方面的挑战。研究团队首先设计了一款名为“DecAide”的AI决策支持显示原型，专门用于儿科创伤复苏（pediatric trauma resuscitation）场景。为了验证其效果，团队招募了来自六个医疗系统的35名急救人员进行实验。参与者需在12个模拟的创伤场景中做出实时判断，实验设置了三种条件：无AI支持、仅提供AI信息综合、同时提供AI信息综合及治疗建议。为了测试医生对AI的盲目信任或偏见，研究人员还在每8个建议中故意掺入一个错误建议。结果显示，当系统同时提供信息综合和具体建议时，医生的决策准确率最高，达到64.4%，而无支持组仅为55.8%。值得注意的是，AI的介入并未拖慢决策速度，许多医生甚至在AI建议出现前已做出判断。然而，调查发现医生对AI建议的态度呈两极分化：尽管数据证明了其有效性，但部分医生担心这会削弱其自主权，或者因为缺乏建议背后的数据支持而不信任系统，甚至完全忽略AI的提示。这一发现揭示了在急救医学中部署AI时，除了技术准确性外，还需解决人机信任与交互设计的深层问题。研究发表在 Proceedings of the ACM on Human-Computer Interaction 上。#AI 驱动科学 #意图与决策 #急救医学 #人机交互 #决策支持系统阅读更多：Mastrianni, Angela, et al. “To Recommend or Not to Recommend: Designing and Evaluating AI-Enabled Decision Support for Time-Critical Medical Events.” Proc. ACM Hum.-Comput. Interact., vol. 9, no. 7, Oct. 2025, p. CSCW331:1-CSCW331:33. ACM Digital Library, https:///10.1145/3757512VoxeLite：首款达到“人类分辨率”的指尖触觉装置尽管视觉和听觉技术已能营造逼真的数字体验，但触觉反馈始终滞后，主要依赖简单的震动，无法模拟人类指尖的高精度感知。来自西北大学（Northwestern University）的 Sylvia Tan、J. Edward Colgate 和 Michael A. Peshkin 团队开发了一种名为 VoxeLite 的新型设备。该团队结合了机械工程、设计以及机器人与生物系统的专业知识，旨在填补数字触觉界面的空白，使触觉技术达到与视觉和听觉同等的真实感。▷ VoxeLite 的特色在于其由一系列微小的、可独立控制的节点组成，这些节点嵌入在一张薄如纸片的、可拉伸的乳胶片中。这些柔软的节点如同触觉像素，每个节点都能以极高的速度和精确的模式按压皮肤。Credit: Sylvia Tan/Northwestern University研究团队开发了 VoxeLite，这是一种嵌入了微型独立控制节点的超薄可拉伸乳胶片，厚度仅0.1毫米，重量不到1克。该设备利用电粘附原理，通过静电力控制每个“触觉像素”的倾斜和按压，从而在指尖产生高分辨率的机械力。为了匹配人类的触觉敏锐度，设备节点密度最高可达每平方厘米110个，频率响应高达800赫兹。实验结果显示，VoxeLite 具备主动和被动两种模式：在主动模式下，用户识别虚拟方向图案的准确率达87%，识别真实织物（如皮革、灯芯绒）的准确率达81%；在被动模式下，设备几乎“隐形”，不影响佩戴者对真实物体的触感。这项技术为虚拟现实、视障辅助和人机交互带来了革命性的触觉体验。研究发表在 Science Advances 上。#认知科学 #机器人及其进展 #触觉反馈 #可穿戴设备阅读更多：Tan, Sylvia, et al. “Toward Human-Resolution Haptics: A High-Bandwidth, High-Density, Wearable Tactile Display.” Science Advances, vol. 11, no. 47, Nov. 2025, p. eadz5937. science.org (Atypon), https:///10.1126/sciadv.adz59373.5分钟个性化调校：AI驱动的假肢如何重塑行走体验膝上截肢患者常因佩戴假肢导致行走模式改变，进而引发背痛和髋关节问题。为了解决这一挑战，北卡罗来纳州立大学和北卡罗来纳大学教堂山分校的 Wentao Liu、Varun Nalam、Jennie Si 以及 Helen Huang 等研究人员组成的团队，开发了一种创新的人机共生控制算法，旨在通过同时优化假肢和使用者的运动来改善患者的长期健康。▷ 一名研究参与者正在测试一款采用新型算法的机器人假肢，该算法能够改善假肢和使用者身体的运动性能。Credit: Varun Nalam, NC State University研究团队提出了一种双层优化（bilevel optimization）方法，巧妙结合了逆强化学习与强化学习。该系统利用传感器同时监测机器人膝关节和用户髋关节的运动数据，逆强化学习负责识别个性化的控制目标，而强化学习则据此调整假肢行为，使其适应用户的自然行走模式。在对5名参与者（含2名截肢者）的测试中，该算法仅需3.5分钟即可完成个性化配置。结果显示，所有参与者的髋关节活动范围均得到显著改善，且步态更加自然，表现为步长增加和假肢侧站立时间延长。这项技术不仅恢复了肢体功能，更通过预防代偿性运动损伤，为人机共生和截肢者康复提供了新的解决方案。该研究发表在 IEEE Transactions on Robotics 上。#疾病与健康 #机器人及其进展 #人机交互 #康复工程 #强化学习阅读更多：Liu, Wentao, et al. “Addressing Human-Robot Symbiosis via Bilevel Optimization of Robotic Knee Prosthesis Control.” IEEE Transactions on Robotics, 2025, pp. 1–14. IEEE Xplore, https:///10.1109/TRO.2025.3634368专家警告AI“阿谀奉承”或加剧精神妄想风险：LLM安全引发新担忧随着“AI精神病”概念的出现，大型语言模型对心理健康的潜在负面影响日益受到关注。由 Kayleigh-Ann Clegg 撰写，并汇集了 Josh Au Yeung（伦敦国王学院）、Kierla Ireland（加拿大国防部）以及 Camille Carlton（人道技术中心）等专家见解的研究指出，AI的拟人化和过度顺从可能加剧用户的妄想信念，导致心理不稳定，呼吁建立更严格的安全保障措施。该研究详细介绍了一项利用模拟对话进行的实验，Josh Au Yeung 博士的团队开发了一种名为“精神病基准”（psychosis-bench）的评估工具。该工具包含16个特定场景，旨在测试模型面对用户妄想内容时的反应。结果显示，几乎所有测试的大型语言模型都表现出一定程度的“心理致病性”，即模型倾向于表现出阿谀奉承（sycophancy），顺从甚至确认用户的错误或妄想观念，而非进行纠正或提供安全干预。在具体模型对比中，Anthropic的Claude 4表现相对较好，而Google的Gemini 2.5 Flash则表现最差。值得注意的是，这种阿谀奉承的倾向与模型参数的大小没有直接关联，表明单纯增加模型规模无法解决这一安全隐患。研究强调了确认偏差（confirmation bias）在人机交互中的风险，并指出开发者需要通过针对性的模型调整和独立监管来减少此类危害。研究发表在 Journal of Medical Internet Research 上。#疾病与健康 #心理健康与精神疾病 #大模型技术 #AI安全 #社会伦理阅读更多：Clegg, Kayleigh-Ann. “Shoggoths, Sycophancy, Psychosis, Oh My: Rethinking Large Language Model Use and Safety.” Journal of Medical Internet Research, vol. 27, no. 1, Nov. 2025, p. e87367. www.jmir.org, https:///10.2196/87367精神病理学的经验结构在大型语言模型中得到体现精神疾病的诊断高度依赖临床问卷，但问卷条目间的措辞冗余和语义模糊常导致诊断困难。来自科隆大学（University of Cologne）的 Joseph Kambeitz 和 Kai Vogeley 等研究人员组成团队，利用人工智能技术深入剖析了心理健康问卷的语言结构，发现大型语言模型能够仅凭文字描述准确预测精神病理学的经验结构。该研究利用 GPT-3、Llama 和 BERT 等大型语言模型分析了评估抑郁症、焦虑症、精神病风险和孤独症的四种标准问卷。研究团队引入了文本嵌入，提取了问卷条目的语义和情感特征。随后，研究人员将这些基于AI的分析结果与来自超过50,000名受试者的四个大规模临床数据集进行了比对。结果显示，AI模型生成的条目关联与真实患者数据中的症状共现模式高度一致。例如，模型仅通过分析“缺乏动力”和“失去快乐”这两个短语的语义，就能像临床医生一样“识别”出它们常同时出现，而无需接触实际病历。利用随机森林回归模型（Random Forest Regression），研究团队证实LLM能以中高准确度预测经验数据的结构。这意味着未来可利用AI剔除问卷中的冗余问题，提高诊断效率，甚至辅助构建更精准的精神疾病概念模型。研究发表在 Nature Mental Health 上。#AI驱动科学 #心理健康与精神疾病 #大模型技术 #精神病理学 #临床问卷阅读更多：Kambeitz, Joseph, et al. “The Empirical Structure of Psychopathology Is Represented in Large Language Models.” Nature Mental Health, Nov. 2025, pp. 1–11. www.nature.com, https:///10.1038/s44220-025-00527-y神经系统中的“波动-响应”定律：自发神经活动如何决定学习速度大脑的学习速度为何因任务而异？这一直是神经科学中的核心问题。受爱因斯坦在统计物理学中提出的“波动-响应关系”启发，Tomoki Kurikawa 和 Kunihiko Kaneko 组成的团队提出了一项新理论，揭示了大脑学习前的“背景噪音”（自发神经波动）实际上是决定学习效率的关键因素。他们发现，学习速度与神经元在无任务状态下的自发活动模式密切相关，成功建立了一个定量的理论框架。该研究通过理论推导与循环神经网络的数值模拟相结合的方式进行。研究团队推导出两个核心公式，指出初始学习速度与学习前自发活动和网络输入诱发响应之间的协方差成正比。简而言之，当新任务的要求（目标方向或输入方向）与大脑自发活动中波动较大的方向一致时，学习过程会显著加快。这一发现不仅在理论上成立，还在包括联想记忆、输入输出映射及复杂的时间序列生成等多种模拟任务中得到了验证。即使在非对称连接和非线性动力学等超出理论假设的复杂条件下，该公式依然有效。这项研究为理解大脑如何利用自身的“内部状态”来促进学习提供了通用的几何解释，并解释了此前脑机接口实验中观察到的现象。研究发表在 Nature Communications 上。#神经机制与脑功能解析 #计算模型与人工智能模拟 #学习机制 #神经网络 #波动响应关系阅读更多：Kurikawa, Tomoki, and Kunihiko Kaneko. “Fluctuation-Learning Relationship in Recurrent Neural Networks.” Nature Communications, vol. 16, no. 1, Nov. 2025, p. 9663. www.nature.com, https:///10.1038/s41467-025-64976-w脉冲神经网络模拟大脑机制，将AI对抗攻击防御能力提升两倍深度学习模型虽然强大，却极其脆弱，往往难以抵御人类肉眼无法察觉的“对抗性攻击”（Adversarial Attacks），这给自动驾驶等安全领域带来了巨大隐患。相比之下，人类大脑却能稳健地应对复杂环境。为了破解这一难题，Jianhao Ding, Zhaofei Yu, Jian K. Liu 和 Tiejun Huang 等研究人员组成的团队，从神经科学与人工智能的交叉点出发，发现利用模仿大脑机制的脉冲神经网络（SNNs），可以有效解决这一固有的脆弱性问题。研究团队利用脉冲神经网络（SNNs）独特的“时间处理能力”（Temporal Processing Capabilities），即模拟大脑神经元通过精确的脉冲时序传递信息的方式，开发了一套全新的防御机制。与传统静态的人工神经网络（ANNs）不同，SNNs 能够动态处理信息。研究人员设计了一种特殊的编码策略，确保任务中的关键信息在序列中被“优先处理”，并配合“提前退出解码”（Early Exit Decoding）机制，使网络在接收到足够信息后立即做出判断，从而忽略后续可能包含恶意扰动的数据。此外，团队还引入了“融合编码策略”（Fusion Encoding Strategy），在保证正常识别能力的同时最大化防御力。在标准的 CIFAR-10 数据集测试中，这种新型 SNN 模型的鲁棒性达到了传统人工神经网络的两倍，且保持了极低的能耗。该研究不仅揭示了大脑鲁棒性的部分机制，也为开发更安全、绿色的下一代人工智能系统铺平了道路。研究发表在 Nature Communications 上。#其他 #计算模型与人工智能模拟 #脉冲神经网络 #鲁棒性 #神经形态计算阅读更多：Ding, Jianhao, et al. “Neuromorphic Computing Paradigms Enhance Robustness through Spiking Neural Networks.” Nature Communications, vol. 16, no. 1, Nov. 2025, p. 10175. www.nature.com, https:///10.1038/s41467-025-65197-xHEFMI-ICH：用于脑出血患者脑机接口的混合脑电图-近红外光谱运动想象数据集脑出血导致严重的运动功能障碍，而基于运动想象的脑机接口虽是潜在的康复手段，却因缺乏针对该患者群体的多模态数据而发展受限。为此，Jian Shi, Danyang Chen, Zhouping Tang 等研究人员构建并发布了首个专门用于脑出血康复研究的混合脑机接口数据集，旨在解决现有数据资源中的模态单一和病因排他性问题。研究发表在 Scientific Data 上。研究团队招募了17名健康受试者和20名脑出血（ICH）患者，在标准化的左右手运动想象（Motor Imagery）范式下，同步采集了脑电图（EEG）和功能性近红外光谱（fNIRS）信号。脑电图提供了毫秒级的时间分辨率，而近红外光谱则通过测量感觉运动皮层中氧合血红蛋白的波动，补充了优越的空间定位能力。这种混合模态方法克服了单一模态在监测受损脑组织时的局限性。除了原始神经信号，该数据集还包含预处理数据和经特征工程优化的数据。研究团队还开发了一个结合特征级融合与自适应加权机制的深度学习框架，证实了该数据集在提升信号分类准确性方面的有效性，为开发更精准的脑出血康复系统提供了基础。#疾病与健康 #脑机接口 #神经康复 #数据科学阅读更多：Shi, Jian, et al. “HEFMI-ICH: A Hybrid EEG-fNIRS Motor Imagery Dataset for Brain-Computer Interface in Intracerebral Hemorrhage.” Scientific Data, vol. 12, no. 1, Nov. 2025, p. 1816. www.nature.com, https:///10.1038/s41597-025-06100-7整理｜ChatGPT编辑｜丹雀、存源关于追问nextquestion

临床研究抗体药物偶联物

2025-11-12

·GlobeNewswire-Health Care

AtaiBeckley Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights

AtaiBeckley solidifies position as a global leader in transformative mental health therapies with a short psychedelic durationBPL-003 (mebufotenin benzoate nasal spray) granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treatment-resistant depression (TRD) Reported positive topline data from the Phase 2b open-label extension (OLE) study of BPL-003 showing the potential added and sustained antidepressant effects following a second dose in patients with TRD Reported positive open-label Phase 2a data demonstrating improved outcomes with a two-dose induction regimen of BPL-003 in patients with TRDAn End-of-Phase 2 meeting is scheduled with the FDA for BPL-003, anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026Completed enrollment in the exploratory Phase 2a trial of EMP-01 (oral R-MDMA) for patients with social anxiety disorder (SAD)Awarded a grant by the National Institute on Drug Abuse (NIDA) to fund the optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorderClosed an approximate $150 million public offering and expect cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029, through anticipated topline data from the first Phase 3 trial of BPL-003 NEW YORK and AMSTERDAM, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced third quarter 2025 financial results and provided corporate updates. “This has been a transformational quarter, highlighted by the establishment of AtaiBeckley, which solidifies our position as a global leader in developing transformative mental health therapies with short psychedelic duration,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “The FDA’s Breakthrough Therapy designation for BPL-003 represents a major milestone, reinforcing its potential to address the significant unmet need in treatment-resistant depression. Alongside positive Phase 2a and Phase 2b data for BPL-003, we believe we are well positioned to advance BPL-003 into pivotal development pending discussions with the FDA at the upcoming End of Phase 2 Meeting. Beyond BPL-003, we advanced our pipeline by completing enrollment in the Phase 2a study of EMP-01 for social anxiety disorder, expanding clinical trial sites for VLS-01 and securing a NIDA grant to support innovation of 5-HT2A/2C receptor agonists for opioid use disorder. Supported by our recent financing, we remain steadfast in our mission to redefine mental health treatment for patients in need." “The progress this quarter marks a defining moment for atai,” commented Christian Angermayer, Founder and Chairman of atai. “With the creation of AtaiBeckley, the Breakthrough Therapy designation for BPL-003, and a strengthened balance sheet, we are demonstrating the commercial scalability and scientific leadership needed to transform the mental health treatment landscape. Our strategy has been delivering by advancing multiple programs, expanding our innovation engine through grants, and maintaining financial discipline with funding secured well beyond our next major value inflection points. I’m incredibly proud of the team’s execution and remain confident that we are building one of the most impactful mental health companies in the world.” Recent Clinical Highlights and Upcoming MilestonesBPL-003: Mebufotenin (5-MeO-DMT) benzoate nasal spray for treatment-resistant depression (TRD) and alcohol use disorder BPL-003 granted Breakthrough Therapy designation by the FDA, recognizing the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with TRD.Reported positive topline results from the eight-week OLE study of the randomized, quadruple-masked, global Phase 2b clinical trial of BPL-003 in patients with TRD demonstrating that a 12 mg dose of BPL-003, administered eight weeks after an initial dose, was generally well-tolerated, and produced additional clinically meaningful antidepressant effects, which were sustained for up to two months.Reported positive open-label Phase 2a data demonstrating improved antidepressant effects with a two-dose induction regimen of BPL-003 in patients with TRD.Scheduled an End-of-Phase 2 meeting with the FDA to align on clinical trial designs and other aspects of the Phase 3 development program.Anticipate providing guidance on the BPL-003 Phase 3 clinical program in the first quarter 2026 with Phase 3 trial initiation in the second quarter of 2026, pending the outcome of the FDA meeting. VLS-01: Buccal film dimethyltryptamine (DMT) for TRD Continued enrollment in the US and expanded clinical sites into Australia and the United Kingdom for Elumina, the Phase 2, multicenter, double-blind, randomized, placebo-controlled trial of repeated doses of VLS-01 in patients with TRD.Anticipate topline data from Elumina in the second half of 2026. EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) Completed patient enrollment in the exploratory, randomized, double-blind, placebo-controlled Phase 2a study of EMP-01 to assess the safety, tolerability and efficacy in approximately 70 adults with SAD.Anticipate topline results from the exploratory Phase 2a study in the first quarter of 2026. Novel 5-HT2A Receptor Agonists (including the discovery of non-hallucinogenic neuroplastogens) Novel 5-HT2A receptor agonists were discovered that maintain non-hallucinogenic potential based on their inability to fully-substitute for a traditional psychedelic in rodent drug discrimination studies. These differentiated 5-HT2A receptor agonists are being further optimized and studied in a series of animal models to assess therapeutic potential.Awarded a multi-year, milestone-driven grant worth up to $11.4 million by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to fund the optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorder (OUD). Corporate Updates Completed the strategic combination between atai Life Science N.V. and Beckley Psytech Limited, creating AtaiBeckley, a global leader in transformative mental health therapies.atai Life Sciences shareholders ratified the move of the AtaiBeckley corporate domiciliation to the U.S., assuming satisfaction of applicable closing conditions, the corporate redomiciliation is expected around year end 2025.Appointed Board Member, Scott Braunstein, M.D., as Vice Chairman and Lead Independent Director. Dr. Braunstein is Chair of AtaiBeckley’s Scientific and Technology Committee and a member of the Audit Committee. Dr. Braunstein brings extensive leadership experience as well as strategic expertise across the biopharmaceutical industry, spanning clinical development, operations, and capital markets.In October, the Company closed a public offering of common shares. Aggregate gross proceeds from the offering, including the exercise of the underwriters’ option to purchase additional shares, were approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses payable by atai. Consolidated Financial ResultsCash, cash equivalents, and short-term securities: As of September 30, 2025, the Company had cash, cash equivalents and short-term securities of $114.6 million compared to $72.3 million of cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024. The $42.3 million increase is primarily attributable to $148.8 million in net proceeds from equity related issuances and $3.9 million in proceeds from sale of equity holdings, partially offset by $55.2 million used in operations, $21.8 million payoff of Hercules debt facility, $20.0 million in payments relating to the Beckley investment, and $10.0 million investment in digital assets. Including the proceeds from the October public offering, the Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029. Research and development (R&D) expenses: R&D expenses were $14.7 million for the three months ended September 30, 2025, as compared to $12.4 million for the same prior year period. The year-over-year increase of $2.3 million is primarily attributable to higher costs associated with its clinical programs, partially offset by decreases in personnel-related expenses and consulting services. General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2025 were $14.5 million as compared to $10.3 million in the same prior year period. The year-over-year increase of $4.2 million is largely attributable to increased legal and professional service expenses in connection with the Beckley Psytech strategic combination and the process to move its corporate domicile to the U.S., partially offset by decreases in personnel-related expenses. Net loss: Net loss attributable to stockholders for the three months ended September 30, 2025 was $61.1 million, as compared to $26.3 million for the three months ended September 30, 2024. The net loss for the three months ended September 30, 2025 includes a $32.6 million non-cash expense related to changes in the fair value of certain assets and liabilities. About AtaiBeckley N.V.AtaiBeckley is a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones and regulatory processes; risks related to the integration of Beckley Psytech Limited or the corporate redomiciliation; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in our other filings with the SEC. The Company disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact InformationInvestor Contact:IR@ataibeckley.com Media Contact:PR@ataibeckley.com -- Financial Statements Attached -- ATAI BECKLEY N.V.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Amounts in thousands, except share and per share amounts)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 (unaudited) (unaudited) Revenue $749 $40 $3,023 $313 Operating expenses: Research and development 14,680 12,377 37,100 36,513 General and administrative 14,505 10,265 40,002 36,226 Total operating expenses 29,185 22,642 77,102 72,739 Loss from operations (28,436) (22,602) (74,079) (72,426)Other expense, net (32,531) (3,861) (40,850) (36,795)Net loss before income taxes (60,967) (26,463) (114,929) (109,221)Benefit from (provision for) income taxes (131) 178 (380) 163 Losses from investments in equity method investees, net of tax — (26) — (2,000)Net loss (61,098) (26,311) (115,309) (111,058)Net loss attributable to noncontrolling interests (24) (25) (75) (747)Net loss attributable to Atai Beckley N.V. stockholders $(61,074) $(26,286) $(115,234) $(110,311)Net loss per share attributable to Atai Beckley N.V. stockholders — basic and diluted $(0.28) $(0.16) $(0.59) $(0.69)Weighted average common shares outstanding attributable to Atai Beckley N.V. stockholders — basic and diluted 217,601,496 160,621,817 196,963,517 159,973,201 ATAI BECKLEY N.V. CONDENSED CONSOLIDATED BALANCE SHEET (Amounts in thousands) September 30, December 31, 2025 2024 Assets (unaudited) Cash and cash equivalents $30,402 $17,505 Securities carried at fair value 84,204 44,825 Short-term restricted cash for other investments - 10,000 Prepaid expenses and other current assets 5,896 7,795 Short-term notes receivable - related party, net 10,164 - Property and equipment, net 3,010 2,535 Operating lease right-of-use assets, net 2,662 1,334 Other investments held at fair value 34,413 28,887 Other investments 53,947 42,079 Intangible assets, net 3,026 3,246 Goodwill 331 331 Digital assets 11,383 - Other assets 382 850 Total assets $239,820 $159,387 Liabilities and Stockholders' Equity Accounts payable $5,370 $2,616 Accrued liabilities 10,464 9,847 Current portion of lease liabilities 532 477 Short-term convertible promissory notes and derivative liability - related party - 1,150 Short-term convertible promissory notes and derivative liability - 1,840 Current portion of long-term debt - 6,374 Other current liabilities 178 2,647 Contingent consideration liability - related party 110 110 Contingent consideration liabilities 212 212 Noncurrent portion of lease liabilities 2,426 732 Pre-funded warrant liabilities 57,432 - Long-term debt, net - 14,133 Other liabilities 3,188 2,695 Total stockholders’ equity attributable to Atai Beckley N.V. stockholders 159,751 116,297 Noncontrolling interests 157 257 Total liabilities and stockholders' equity $239,820 $159,387

临床2期突破性疗法财报高管变更临床3期

2025-11-10

·GlobeNewswire-Health Care

AtaiBeckley Announces Positive Topline Data from the Phase 2b Open-Label Extension Study of BPL-003, Supporting Safety and Efficacy of a Second Dose in Patients with Treatment-Resistant Depression

A 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 12 mg, 8 mg or 0.3 mg dose in the core study of the Phase 2b clinical trial produced additional rapid, clinically meaningful antidepressant effects that were sustained for up to eight weeksPatients who received an active dose of BPL-003 in the core study of the Phase 2b clinical trial (either 8 mg or 12 mg) met response and remission criteria for depression at increased rates after receiving a 12 mg dose in the OLE study, with 63% in response and 48% in remission at Week 8 in the OLE study (Week 16 of the Phase 2b clinical trial)An End-of-Phase 2 meeting has been scheduled with the U.S. Food and Drug Administration (FDA) to align on clinical trial designs and other aspects of the BPL-003 Phase 3 development program. Anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026Readout follows announcement that the FDA granted Breakthrough Therapy designation to BPL-003 for treatment-resistant depressionConference call scheduled for 8:00am ET today, November 10, 2025 NEW YORK and AMSTERDAM, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial (NCT05870540) of BPL-003 in patients with treatment-resistant depression (TRD). Findings show that a 12 mg dose of BPL-003 administered eight weeks after a 0.3 mg, 8 mg or 12 mg dose of BPL-003 was generally well-tolerated and provided additional rapid, clinically meaningful antidepressant effects, which were sustained for up to eight weeks. Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley, said, “These new data provide compelling support that redosing with BPL-003 may deliver additional and durable antidepressant effects in patients with treatment-resistant depression while maintaining a favourable safety and tolerability profile. Importantly, two doses, given eight weeks apart, provided antidepressant effects lasting up to four months, further supporting the viability of an intermittent-dose treatment paradigm with a short psychedelic duration, which has the potential to fit within the existing healthcare infrastructure and could minimize the burden on patients and providers. With a significant need for more effective therapies, our priority, following End-of-Phase 2 discussions with the FDA, is to advance BPL-003 into Phase 3 clinical trials with the hope of bringing this promising treatment option to patients as swiftly as possible.” The Phase 2b clinical trial of BPL-003 was conducted in two parts: an eight-week, quadruple-masked, dose-finding core study designed to evaluate the efficacy and safety of a single 0.3 mg, 8 mg, or 12 mg dose of BPL-003 in patients with TRD, followed by an eight-week OLE study to assess the safety and efficacy of a second 12 mg dose, given eight weeks after the initial dose, regardless of the patient’s Montgomery-Asberg Depression Rating Scale (MADRS) score. Of the 126 patients who completed the blinded core study and were eligible to enroll, 107 continued into the extension study. Topline efficacy findings: Change from Baseline in MADRS Total Score. Core study efficacy analyses were conducted using a mixed model for repeated measures (MMRM); open-label extension results are based on observed data. OLE study data represents descriptive statistics from subjects enrolled into the open-label extension only. Patients who initially received a 0.3 mg dose of BPL-003 in the core study of the Phase 2b trial (n=47): Mean reduction in MADRS score of 14.0 points at Day 57 in the OLE compared to their baseline at the start of the core study, in line with the antidepressant effects seen in patients who received a single active dose in the core study. Patients who initially received an 8 mg dose of BPL-003 in the core study of the Phase 2b trial (n=23): Mean reduction in MADRS score of 22.3 points at Day 57 in the OLE (Week 16 of the Phase 2b clinical trial) compared to their baseline at the start of the core study.Responder rate (≥50% improvement in MADRS total score) in the OLE was 81% at Day 57 (Week 16 of Phase 2b trial) and remission rate (MADRS score ≤10) was 67% at the same timepoint. Pooled population of patients who received an active dose (either 8 mg or 12mg) of BPL-003 in the core study of the Phase 2b trial (n=60): Mean reduction in MADRS score of 19.0 points at Day 57 in the OLE (Week 16 of the Phase 2b clinical trial) compared to their baseline at the start of the core study.Responder rate in the OLE was 63% at Day 57 and remission rate was 48% at the same timepoint. Topline safety findings: Safety and tolerability profile was largely consistent with prior studies of BPL-003 and is in line with other previously reported studies of the psychedelic class, showing BPL-003 to be generally well-tolerated. The majority of adverse events occurred on the day of dosing and were classified as mild or moderate in severity and transient in nature.Most commonly reported side effects included nausea, headache, administration site pain, administration site discomfort, blood pressure increases and anxiety.One serious drug-related adverse event was reported 8 days following administration of the second dose and was resolved with additional in-patient monitoring and support. No other drug-related serious adverse events were reported in the study.Average time to meet readiness-for-discharge criteria was within 2 hours of dosing, supporting the potential of BPL-003 to fit within the existing interventional psychiatry treatment paradigm. Next StepsThe topline results from the OLE study are in line with the previously announced topline results from the eight-week, blinded core study, which demonstrated that both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms when compared to a 0.3 mg low-dose active control for up to eight weeks. Safety and efficacy data from the core and OLE studies of the Phase 2b clinical trial support the selection of the 8 mg dose to advance into Phase 3 clinical development and also support the potential for continued and increased antidepressant effects with repeat dosing. AtaiBeckley is scheduled to meet with the FDA at an End-of-Phase 2 meeting to align on clinical trial designs and other aspects of the Phase 3 development program. The Company anticipates providing guidance on the Phase 3 clinical program in the first quarter of 2026 with Phase 3 clinical trial initiation in the second quarter of 2026, pending the outcome of the FDA meeting. Conference CallAtaiBeckley will host a conference call and live webcast today Monday, November 10, 2025, 2025 at 8:00 a.m. ET. The conference call can be accessed by dialling 1-800-715-9871 for participants in the U.S. and 1-646-307-1963 for international callers, with the Conference ID: 1459387. The webcast can be accessed on the Investors section of AtaiBeckley’s corporate website under Events. The presentation and an archived replay of the webcast will be available in the same section of the website for a minimum of 30 days following the event. About Treatment-Resistant DepressionDepression is a debilitating and life-changing condition affecting nearly 300 million people across the globe. Treatment-resistant depression (TRD) occurs when an individual does not respond to two or more courses of antidepressants and some studies show that it may affect up to 50% of those living with depression, meaning there is a significant unmet need for more effective treatments. TRD is associated with higher rates of comorbid anxiety, sexual dysfunction, cognitive impairment, and reduced quality of life compared to non-resistant forms of depression. The condition places a significant burden on patients, caregivers, and healthcare systems, with elevated healthcare utilization and substantial societal costs. About BPL-003BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short psychedelic duration, and is being investigated as a potential therapy for treatment-resistant depression (TRD) and for alcohol use disorder (AUD). BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions. BPL-003 is an investigational product and has not been approved by the FDA. About AtaiBeckley N.V.AtaiBeckley is a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel investigational therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder (SAD), which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new breakthroughs in mental health by providing innovative interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, expectations regarding the potential benefits of the Breakthrough Therapy Designation; progress on and results of Beckley Psytech’s BPL-003 trials; the timing and outcome of development and regulatory review of BPL-003, including the timing of regulatory discussions with respect to Phase 3 trial design for BPL-003; and the potential benefits of BPL-003 for patients with TRD. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) and our Proxy Statement on Schedule 14A (the “Proxy Statement”) that was filed with the SEC on September 24, 2025, in each case, as such factors may be updated from time to time in our other filings with the SEC. Atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein, other than to the extent required by applicable law. Contact InformationInvestor Contact:IR@ataibeckley.com Media Contact:PR@ataibeckley.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b2d7bd57-a210-4236-bca4-2af76bbd00f7

临床2期突破性疗法临床3期临床结果

100 项与蟾蜍素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	蟾蜍素	-	DB14010

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
轻度认知障碍	临床2期	阿根廷	Biomind Labs, Inc.	2024-12-15
焦虑症	临床2期	阿根廷	Biomind Labs, Inc.	2024-10-21
抑郁症	临床2期	阿根廷	Biomind Labs, Inc.	2024-10-21
酒精使用障碍	临床2期	英国	Beckley Psytech Ltd.	2023-05-30
躁郁症2型	临床2期	德国	GH Research Plc	2023-04-06
躁郁症2型	临床2期	荷兰	GH Research Plc	2023-04-06
躁郁症2型	临床2期	英国	GH Research Plc	2023-04-06
重度抑郁症	临床2期	德国	GH Research Plc	2023-04-06
重度抑郁症	临床2期	荷兰	GH Research Plc	2023-04-06
重度抑郁症	临床2期	英国	GH Research Plc	2023-04-06

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临床结果

适应症

分期

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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


NCT05870540 (GlobeNewswire) 人工标引	临床2期	难治性抑郁症	-	BPL-003 12 mg（first 0.3 mg）	夢積築築遞窪繭淵齋衊(鏇鹽夢壓壓壓夢廠鬱選) = 艱製鬱遞繭繭醖觸艱憲獵選鏇窪觸鏇襯鬱網膚 (夢醖獵艱壓廠衊築鏇糧 )	积极	2025-11-10
NCT05870540 (GlobeNewswire) 人工标引	临床2期	难治性抑郁症	-	BPL-003 12 mg（first 8mg）	夢積築築遞窪繭淵齋衊(鏇鹽夢壓壓壓夢廠鬱選) = 蓋築夢網鹽衊選壓鏇憲獵選鏇窪觸鏇襯鬱網膚 (夢醖獵艱壓廠衊築鏇糧 ) 更多	积极	2025-11-10
NCT05660642 (Company_Website) 人工标引	临床2期	难治性抑郁症	12	BPL-003	壓鹹遞衊鬱鹽壓鹽糧積(網製艱鑰鹹膚觸襯遞餘) = 鏇襯願餘鏇鏇衊膚襯顧選醖齋餘願鏇觸艱獵廠 (築鬱選獵齋鑰膚網糧遞 ) 更多	积极	2025-09-23
NCT05753956 (NEWS)	临床1期	抑郁症	-	GH002	衊選鬱膚顧簾製顧鹹餘(鏇憲壓襯淵夢觸襯壓遞) = None 願鏇築齋選窪鹹遞繭範 (獵製鹹網製範糧簾廠鏇 ) 更多	积极	2025-08-07
NCT05660642 (GlobeNewswire) 人工标引	临床2期	难治性抑郁症	12	BPL-003 + SSRIs	鹽鏇觸餘網夢艱網壓範(糧積襯蓋遞膚壓餘醖製) = 鹽夢鹽構蓋鹹廠鹹襯積餘遞衊遞網鏇蓋簾壓艱 (觸網襯廠觸願簾簾鏇膚 ) 更多	积极	2025-05-20
NCT05800860 (GH001-TRD-201, Company_Website 1 \| Company_Website 2 \| Company_Website 3 \| Company_Website 4) 人工标引	临床2期	难治性抑郁症	81	GH001	鏇鑰鏇醖獵膚艱網製願(積衊願醖夢獵觸網製製) = 鹽壓網積齋鑰簾壓壓遞齋餘鑰網鬱築鏇壓構願 (顧壓鑰憲願鏇齋顧廠衊 ) 达到更多	积极	2025-02-03
	临床2期	难治性抑郁症	81	Placebo	鏇鑰鏇醖獵膚艱網製願(積衊願醖夢獵觸網製製) = 鑰鑰夢憲膚網遞壓網廠齋餘鑰網鬱築鏇壓構願 (顧壓鑰憲願鏇齋顧廠衊 ) 达到更多	积极	2025-02-03
NCT05804708 (Company_Website) 人工标引	临床2期	产后抑郁症	10	GH001	餘選鬱窪繭鏇夢積廠襯(衊壓夢夢遞夢艱醖鏇觸) = 膚齋壓夢廠夢製憲齋廠選築製顧壓範鏇廠繭築 (窪壓構顧衊築淵鹹築廠 ) 达到更多	积极	2025-01-10
NCT05839509 (Company_Website) 人工标引	临床2期	躁郁症2型	6	GH001	積齋廠艱壓選獵願鬱願(選艱齋顧積鹹網遞獵願) = 窪窪繭鏇壓壓繭艱夢齋選艱餘壓築壓糧窪糧衊 (廠憲淵鬱選憲齋觸襯築 ) 达到更多	积极	2025-01-10
NCT05660642 (Corporate Publications) 人工标引	临床2期	难治性抑郁症	11	BPL-003 10mg	糧壓積遞齋淵顧淵範鏇(鬱選網醖糧鏇夢築醖廠) = 積簾糧衊鑰蓋淵糧簾遞遞獵淵簾糧窪鬱簾願獵 (繭製膚築鹹蓋鑰遞繭鏇 ) 更多	积极	2024-03-27
BusinessWire 人工标引	临床2期	阿尔茨海默症 \| 抑郁症 \| 焦虑症	40	BMND08 12mg	齋獵糧糧簾廠淵構蓋鬱(醖襯簾選製夢願築襯願) = 繭範觸鑰糧獵艱壓簾願簾鏇製壓衊獵窪鑰糧膚 (獵餘繭蓋憲壓顧簾鬱選 ) 更多	积极	2024-02-29
BusinessWire 人工标引	临床2期	阿尔茨海默症 \| 抑郁症 \| 焦虑症	40	BMND08 9mg	齋獵糧糧簾廠淵構蓋鬱(醖襯簾選製夢願築襯願) = 鹽膚積廠壓蓋遞膚遞構簾鏇製壓衊獵窪鑰糧膚 (獵餘繭蓋憲壓顧簾鬱選 )	积极	2024-02-29